[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiopulmonary-bypass\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiopulmonary-bypass":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,44,75,97,131,154,180,211,236,260,295,325,355,375,400,427,454,491,515,542,583,607,649,677,706],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632789","comparison-of-femorofemoral-bypass-and-left-heart-bypass-techniques-in-open-thoracoabdominal-aortic-aneurysm-repair-100632789",false,"NCT07518251","CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair","Comparison of Femorofemoral Bypass and Left-Heart Bypass Techniques in Open Thoracoabdominal Aortic Aneurysm Repair: A Study Protocol for Multicenter, Two-Arm, Open-Label, Randomized, ParalleI-Controlled Non-Inferiority Trial","REPAIR","Inclusion Criteria:\n\n1. Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC\u002FAHA Guideline for the Diagnosis and Management of Aortic Disease;\n2. Adult patients (≥18 years old);\n3. Indications for TAAAR are available and requiring cardiopulmonary bypass;\n4. Signed informed consent and availability for follow-up.\n\nExclusion Criteria:\n\n1. History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;\n2. History of severe cerebral infarction (with cerebral infarction sequels);\n3. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;\n4. History of infectious aortic diseases;\n5. History of malignancy or previous radiotherapy;\n6. Pregnant or feeding women, or anyone planning to reproduce during the test period;\n7. Participating in any other clinical trial;\n8. Having other causes not eligible for operation.","ALL","18 Years",{"count":21,"type":22},236,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.",[28,29,30],"Thoracoabdominal Aortic Aneurysm","Cardiopulmonary Bypass","Open Repair","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2026-03-06",{"date":39,"type":22},"2028-08",{"name":41,"class":42},"Beijing Anzhen Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100644603","personalized-blood-transfusion-protocol-for-cardiac-patients-100644603","NCT07671469","Personalized Blood Transfusion Protocol for Cardiac Patients","Personalized (Demand-Informed) Blood Transfusion Protocol for Cardiac Patients","PerP","Inclusion Criteria:\n\n* Adults 18 years or older scheduled for cardiac surgery using the heart-lung machine (cardiopulmonary bypass), such as bypass, valve, or combined procedures\n* Moderate-to-high surgical risk (e.g., EuroSCORE II ≥ 3% or equivalent)\n* Allogeneic red blood cell transfusion is considered likely\n* Able to provide informed consent and understand randomization to different transfusion thresholds\n* Willing to receive blood products and follow study transfusion thresholds from anesthesia induction until hospital discharge or day 28, whichever comes first\n\nExclusion Criteria:\n\n* Refusal of or contraindication to allogeneic blood (e.g., Jehovah's Witness or formal directive against transfusion), or enrollment in a preoperative autologous donation program\n* Emergency or salvage procedures where protocol triggers are impractical (e.g., active arrest, aortic dissection with collapse)\n* Heart transplantation, durable ventricular assist device implantation, or surgery solely for VAD insertion\n* Off-pump bypass or other procedures not using cardiopulmonary bypass\n* Severe preoperative anemia (e.g., hemoglobin \\\u003C 8 g\u002FdL) or chronic transfusion-dependent anemia\n* Conditions preventing protocol adherence (e.g., anticipated massive hemorrhage, known bleeding disorder, very low platelets, uninterruptible dual antiplatelet\u002Fanticoagulant therapy)\n* Chronic dialysis dependence or established end-stage renal disease (eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m² or on maintenance renal replacement therapy) prior to surgery.\n* Pregnancy or lactation\n* Enrollment in another interventional trial affecting transfusion practice or hemoglobin thresholds\n* Unable to provide informed consent (e.g., severe cognitive impairment without a legally authorized representative)",{"count":53,"type":22},900,[25],"This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. The other approach adds each patient's own physiology - such as oxygen levels and lactate - to help decide whether a transfusion is truly needed, within a safe range. The investigators want to learn whether the personalized approach is as safe as the standard approach for major outcomes after heart surgery, while reducing the amount of blood transfused. Participants may also choose to give blood and stool samples to a research biobank for future studies on recovery after cardiac surgery.",[57,58,59,29],"Cardiac Surgery","Blood Transfusion","Anemia",[61,62,63,64,65],"restrictive transfusion","hemoglobin trhreshold","oxygen delivery","cardiac surgery","ICU","NOT_YET_RECRUITING","2026-06-26",{"date":32,"type":35},{"date":70,"type":22},"2026-09-14",{"date":72,"type":22},"2030-03-15",{"name":74,"class":42},"Yan Mia Min",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":43},"100644980","evaluation-of-the-effectiveness-of-ultrasound-guided-stellate-ganglion-block-in-cardiac-surgery-anesthesia-on-postoperative-recovery-a-multicenter-randomized-double-blind-trial-100644980","NCT07676487","Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery: A Multicenter, Randomized, Double-Blind Trial","ECLAIR","Inclusion Criteria:\n\n* Individuals who have provided their free and informed written consent\n* Age ≥18 years\n* Patients scheduled to undergo elective cardiac surgery (≥24 hours) with cardiopulmonary bypass (CPB): valve surgery, aorto-coronary bypass surgery, or combined surgery (\\>2 procedures)\n\nExclusion Criteria:\n\n* Adult under guardianship\n* Patient not enrolled in a social security program\n* Patient who has previously been included in the study (e.g., repeat surgery)\n* Patient with hypersensitivity to local anesthetics or to any of the excipients in the products used\n* Preoperative AC\u002FFA\n* Hypovolemia\n* Severe hypotension\n* Acute porphyria\n* Pregnant, laboring, or breastfeeding women",{"count":83,"type":22},250,[25],"Heart surgery is a complex and delicate procedure that affects more than one million people worldwide each year. Patients who undergo this surgery are generally elderly and have multiple comorbidities, which places them in high-risk categories (ASA III or IV). This frailty, combined with a loss of physiological reserve, makes these patients particularly vulnerable to postoperative complications, which can range from cardiovascular disorders to neurological, respiratory, renal, gastrointestinal, infectious, and hematological complications.\n\nIn this context, the quality of postoperative recovery is crucial because it reflects the patient's postoperative health status. The quality of recovery encompasses several dimensions, such as pain, return to independence, sleep quality, and mental state. Optimal anesthesia-which goes beyond simply minimizing pain-requires proactive management of all these dimensions. Current research in cardiac surgery focuses on optimizing anesthesia strategies, particularly the choice between opioid and non-opioid anesthesia, as well as the complementary use of regional analgesia. However, studies providing clear recommendations on these topics are still limited.\n\nAmong the techniques explored, the ultrasound-guided stellate ganglion block (SGB) stands out due to its numerous positive clinical effects. This block, which involves the ultrasound-guided injection of a local anesthetic into the stellate ganglion, produces a temporary sympathetic block that reduces the activity of the autonomic nervous system during surgery. Several studies suggest that SGB could significantly improve the quality of postoperative recovery, particularly in terms of pain reduction, sleep quality, and a lower incidence of cardiac arrhythmias. A meta-analysis has shown that SGB promotes the recovery of gastrointestinal function following various surgical procedures. In major thoracic surgery, it has been observed that SGB reduces the incidence of perioperative atrial and ventricular fibrillation.\n\nAlthough these results are promising, data from randomized trials in cardiac surgery are still limited. A pilot study demonstrated the feasibility and safety of SGB in this type of surgery, with a reduced incidence of atrial fibrillation. However, further studies are essential to confirm these results and assess the impact of SGB on the quality of recovery following anesthesia in cardiac surgery.\n\nThe hypothesis of this study is that performing a stellate ganglion block during general anesthesia improves the quality of recovery in all its aspects (pain, well-being, sleep, etc.). This hypothesis warrants in-depth exploration to optimize postoperative care and improve long-term outcomes for patients undergoing complex cardiac surgery.",[87,29,88],"Undergo Elective Cardiac Surgery","CPB","2026-06-24",{"date":32,"type":35},{"date":92,"type":22},"2026-07",{"date":94,"type":22},"2028-02",{"name":96,"class":42},"Centre Hospitalier Universitaire Dijon",{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":122,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":129,"locationsCount":43},"100642312","risk-factors-of-atrial-fibrillation-after-cardiac-surgery-100642312","NCT07625033","Risk Factors of Atrial Fibrillation After Cardiac Surgery","PFAS","Inclusion Criteria:\n\n* age \\>18\n* having undergone a scheduled cardiac surgery in the study center\n* having agreed to the reuse of their hospital care data\n\nExclusion Criteria:\n\n* Atrial fibrillation at the admission in hospital.",{"count":105,"type":22},918,"OBSERVATIONAL","Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death. Preventing the occurrence of these arrhythmias is a major challenge. This study aims to investigate risk factors and protective factors regarding atrial fibrillation and other iatrogenic cardiac arrhythmias after cardiac surgery, particularly innovative anesthetic strategies such as stellar ganglion blockade which have been recently implemented in our center.",[57,109,110,29,111,112,113,114,115,116,117,118,119,120,121],"Peri Operative Medicine","Thoracic Surgery","Coronary Artery Bypass","Heart Valve Prosthesis Implantation","Aortic Valve Replacement","Perioperative Medicine","Preoperative Care","Intraoperative Care","Postoperative Care","Enhanced Recovery After Surgery","Anesthesia","Cardiac Anesthesia","Intensive Care Unit",[123],"Stellar Ganglion Blockade, SGB, cardiac surgery","2026-06-23",{"date":126,"type":35},"2026-06-25",{"date":34,"type":22},{"date":34,"type":22},{"name":130,"class":42},"Centre Hospitalier Régional Metz-Thionville",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100644555","phase-4-angiotensin-ii-for-post-cardiac-surgery-vasoplegia-angiiv-100644555","NCT07671365","Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)","ANGII_V","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n  1. Provision of signed and dated informed consent form\n  2. Stated willingness to comply with all study procedures and availability for the duration of the study\n  3. Male or female, aged 18 or over\n  4. Exhibiting vasoplegia or vasoplegic shock following surgeries involving cardiopulmonary bypass\n  5. MAP below results below 65mmHg\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Current use of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs)\n  2. Presence of treatment with high-dose glucocorticoids\n  3. Pregnancy or lactation\n  4. Known allergic reactions to components of the Giapreza, \\\u003Cspecify components\u002Fallergens\\>\n  5. Febrile illness within \\\u003Cspecify time frame\\>\n  6. Treatment with another investigational drug or other intervention within \\\u003Cspecify time frame\\>\n  7. Current smoker or tobacco use within \\\u003Cspecify timeframe\\>\n  8. Currently receiving VA ECMO for cardiogenic shock\n  9. Experiencing uncontrolled hemorrhage\n  10. Presenting with burns over 20% or more of body, acute coronary syndrome, bronchial spasms, liver failure, mesenteric ischemia, abdominal aortic aneurysm, or an absolute neutrophil count less than 1000 cubic millimeters","94 Years",{"count":140,"type":22},329,[142],"PHASE4","The goal of this study is to conduct a prospective trial implementing a modified version of the Emory Protocol for administering ANG II to patients with post cardiac bypass vasoplegia. The main questions we aim to answer are: 1.) does administration of improve mortality, 2.) does the administration of Ang II using the modified protocol shorten the time needed to reach optimal MAP, 3.) does the administration of Ang II using the modified protocol shorten length of stay in the ICU and hospital? Researchers will compare outcomes from the interventional group to historical controls who did not receive Ang II using the modified protocol.",[145,29,146],"Vasoplegic Shock","Vasoplegia","2026-06-22",{"date":67,"type":35},{"date":92,"type":22},{"date":151,"type":22},"2030-08",{"name":153,"class":42},"Methodist Healthcare System of San Antonio",{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":43},"100643453","preventive-narrative-exposure-intervention-for-ptsd-in-icu-patients-after-cardiopulmonary-bypass-cardiac-surgery-100643453","NCT07632131","Preventive Narrative Exposure Intervention for PTSD in ICU Patients After Cardiopulmonary Bypass Cardiac Surgery","Effects of Preventive Narrative Exposure Intervention on Posttraumatic Stress Disorder Among ICU Patients After Cardiopulmonary Bypass Cardiac Surgery: A Randomized Controlled Trial","ICU-pNET","Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Scheduled to undergo cardiac surgery with cardiopulmonary bypass, with planned postoperative admission to the cardiac surgical intensive care unit and an expected ICU stay of more than 24 hours.\n3. The participant is able to communicate effectively, and the participant and family members are willing to cooperate with the study.\n4. Conscious before the first postoperative intervention, negative for delirium as assessed by the Confusion Assessment Method for the Intensive Care Unit, and able to understand and complete the intervention and related assessments.\n\nExclusion Criteria:\n\n1. Experienced severe traumatic events within the past year, such as diagnosis of a major disease unrelated to the current cardiac condition in the participant or an immediate family member, or death of an immediate family member or significant other.\n2. Currently receiving treatment for mental disorders, including pharmacological treatment or psychotherapy for conditions such as depressive disorder, anxiety disorder, bipolar disorder, or schizophrenia spectrum disorders.\n3. History of a clearly diagnosed severe mental disorder, or mental abnormalities caused by organic brain disease.",{"count":163,"type":22},100,[25],"This clinical trial aims to evaluate whether an ICU-based preventive narrative exposure intervention can help prevent posttraumatic stress symptoms in adult patients after cardiac surgery with cardiopulmonary bypass.\n\nThe study will include adult patients who undergo cardiac surgery with cardiopulmonary bypass and are admitted to the cardiac surgical intensive care unit. Participants will be randomly assigned to either the intervention group or the control group.\n\nParticipants in the control group will receive routine care and routine psychological support. Participants in the intervention group will receive routine care plus an ICU-based preventive narrative exposure intervention supported by an ICU visitor book. The intervention includes preoperative education, review of ICU experiences, construction of a timeline, guided narration of stressful ICU-related events, and integration of the experience before discharge.\n\nThe ICU visitor book includes selected photos, family messages, and key recovery events. It is used to help patients better understand and organize their ICU experience.\n\nResearchers will compare the intervention group with the control group to see whether the intervention reduces posttraumatic stress symptoms. The primary outcome is posttraumatic stress symptoms at 1 month after discharge. Secondary outcomes include posttraumatic stress symptoms at 3 months after discharge, ICU memories, anxiety, depression, sleep quality, quality of life, and patient and family satisfaction with ICU care.\n\nThe findings may provide evidence for an early psychological nursing intervention to prevent posttraumatic stress disorder in ICU patients after cardiopulmonary bypass cardiac surgery.",[29,167,168],"Intensive Care Units","Stress Disorders, Post-Traumatic",[29,121,170,168],"Narrative Exposure","2026-06-03",{"date":173,"type":35},"2026-06-08",{"date":175,"type":35},"2026-06-02",{"date":177,"type":22},"2027-04-30",{"name":179,"class":42},"First Affiliated Hospital of Fujian Medical University",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":43},"100643703","bedside-assessment-of-right-ventricular-output-lying-in-prone-or-supine-position-100643703","NCT07632027","Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine Position","The BAROLO Study Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine Position. Hemodynamic Changes Due to Prone Position in Patients After Cardiac Surgery - a Prospective Randomized Controlled Trial Evaluating the Effect of Prone Position on Right Heart Function","BAROLO","Inclusion Criteria:\n\n* Scheduled for cardiac surgery using cardiopulmonary bypass\n\nExclusion Criteria:\n\n* BMI \\>40\n* Emergency surgery\n* In need of secondary surgery\n* Advanced grown up congenital heart disease\n* Pulmonary disease\n* Hemodynamic instability with Norepinephrine \\>0.4mcg\u002Fkg\u002Fmin\n* Any condition which, in the judgement of the investigator, might increase the risk to the patient",{"count":189,"type":22},80,[25],"Right ventricular failure (RVF) is a common complication to cardiac surgery, which is associated to mortality, kidney failure, stroke, prolonged mechanical ventilation and ICU stay. The right ventricle is particularly vulnerable to an increased afterload. By increasing pulmonary vascular resistance (PVR), atelectasis might mitigate a negative effect on the right ventricle.\n\nRecruitment maneuvers have been shown to resolve atelectasis and improve hemodynamics by increasing cardiac output and lowering PVR. However these maneuvers transiently raise airway pressures, which in turn increases right ventricular afterload, a situation often poorly tolerated by patients with RVF.\n\nProne position is used in patients with respiratory failure and has been shown to decrease mortality in patients with ARDS. Prone position decreases atelectasis and moves ventilation dorsally. In ARDS it also seems to mediate beneficial hemodynamic effects such as an increase in cardiac output and a decrease in PVR.\n\nThe investigators hypothesis is that prone position early after cardiac surgery will increase cardiac output by recruitment of atelectasis and thereby decrease PVR.",[193,194,195,196,197,198,199,200,201,202,57,203,29],"Right Ventricular Function","Prone Position","Atelectasis","Atelectases, Postoperative Pulmonary","Cardiac Output","Vasoconstriction","Heart Failure","Recruitment Maneuver","Respiratory Mechanics","Pulmonary Arterial Pressure","Cardiac Surgery Recovery",{"date":173,"type":35},{"date":206,"type":22},"2026-09",{"date":208,"type":22},"2028-10",{"name":210,"class":42},"Sahlgrenska University Hospital",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":43},"100640436","change-in-platelet-lipid-metabolism-and-procoagulant-phenotype-induced-by-cardiopulmonary-bypass-impact-on-postoperative-inflammatory-response-and-bleeding-complications-during-cardiac-surgery-100640436","NCT07630987","Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.","PLACARD","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old) suffering from coronary disease and\u002For severe valvular dysfunction (mitral or aortic) undergoing elective coronary angiography or cardiac surgery with cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Uninterrupted preoperative dual antiplatelet therapy\n* Active chronic inflammatory disease\n* Recent chemotherapy or immunotherapy (\\\u003C 3 months)\n* Active solid malignancy\n* History of hematologic malignancy\n* Hemophilia or other coagulopathy\n* History of thrombocytopenia (\\\u003C 100,000 platelets\u002Fmm³)\n* Recent administration of thrombopoietin receptor agonist or immunoglobulins\n* History of thrombopathy, thrombocytosis, or myeloproliferative syndrome\n* History of heparin-induced thrombocytopenia (HIT)\n* Cirrhosis or hepatic fibrosis (with or without hypersplenism)\n* History of splenectomy, regardless of initial indication\n* History of systemic autoimmune disease (e.g., systemic lupus erythematosus, scleroderma, antiphospholipid syndrome, systemic vasculitis)\n* Recent major surgery (\\\u003C 3 months)\n* Severe renal insufficiency (eGFR ≤ 30 mL\u002Fmin\u002Fm²) with or without dialysis\n* Recent or chronic corticosteroid therapy\n* Recent acute coronary syndrome, STEMI type (\\\u003C 3 months)\n* Urgent surgery or procedure\n* Preoperative hemodynamic instability",{"count":163,"type":22},[25],"The PLACARD research project aims to investigate the impact of CPB-induced platelet modifications during cardiac surgery on the post-operative inflammatory response and bleeding complications. Our objectives are to study the impact of CPB on the formation of procoagulant platelets, to assess changes in platelet lipid profile and bioenergetics before, during and after cardiac surgery, and to connect the ex-vivo observations to post-operative clinical and biological parameters of these patients during their stay in cardiovascular intensive care unit.",[57,29,222],"Platelet Activation",[224,225,226,227],"Procoagulant platelets","Platelet lipidomics","Postoperative inflammation","Postoperative bleeding",{"date":229,"type":35},"2026-06-05",{"date":231,"type":22},"2026-05-15",{"date":233,"type":22},"2030-01",{"name":235,"class":42},"Université Catholique de Louvain",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100638939","post-market-clinical-follow-up-study-on-the-performance-and-safety-of-coronary-artery-perfusion-cannula-used-during-cardiopulmonary-bypass-100638939","NCT07620847","Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,\n\n  * Patients for whom the use of a coronary artery perfusion cannula is planned during surgery\n  * Patients who, prior to surgery, have provided consent in the \"Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes\" section regarding the use of their data\n\nExclusion Criteria:\n\n* Patients with ostial calcification and\u002For an ostium that is too small for the cannula tip to fit through,\n\n  * Patients known to have hypersensitivity to any of the materials used in the device components\n  * Patients who have difficulty understanding the study and complying with it\n  * Patients who may pose a conflict of interest (e.g., relatives of employees of the sponsoring company)\n  * Patients who have participated in any clinical trial within the past 30 days",{"count":243,"type":22},20,"Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12\u002F2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.",[29],[247,248,249,250,251,252],"Coronary artery perfusion","coronary ostium","cardioplegia","cardioplegia cannula","antegrade cannula","antegrade cardioplegia","2026-06-01",{"date":175,"type":35},{"date":34,"type":22},{"date":257,"type":22},"2026-10-01",{"name":259,"class":42},"Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":43},"100640008","phase-4-rhbnp-for-prevention-of-cardiac-surgery-associated-acute-kidney-injury-csa-aki-100640008","NCT07617675","rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)","Perioperative Recombinant Human Brain Natriuretic Peptide for Renal Protection in Cardiac Surgery: the PROTECT-CS Randomized Clinical Trial","PROTECT-CS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled (elective) cardiac surgery requiring cardiopulmonary bypass\n* Presence of at least one of the following AKI risk factors:\n* Age ≥ 70 years\n* Preoperative renal impairment (eGFR ≤ 60 mL\u002Fmin\u002F1.73 m² or urine protein ≥ +2 at screening)\n* Type 2 diabetes mellitus\n* Heart failure, defined as NYHA Class II-IV with NT-proBNP ≥ 125 pg\u002FmL at screening; for participants with atrial fibrillation, NT-proBNP ≥ 365 pg\u002FmL is required\n* Able to understand and provide written informed consent, and willing and able to comply with all study protocol requirements\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Severe hypotension (systolic blood pressure ≤ 90 mmHg) at screening\n* Restrictive or obstructive cardiomyopathy, pericarditis, or cardiac tamponade\n* Preoperative chronic kidney disease stage 4 or higher (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²), or renal instability as judged by the investigator\n* Known AKI diagnosed per KDIGO criteria within 48 hours prior to surgery\n* Receipt of any form of renal replacement therapy within 30 days prior to surgery\n* Use of ventricular assist device, intra-aortic balloon pump, or any other mechanical cardiac support device within 7 days prior to surgery\n* Chronic hepatic insufficiency (Child-Pugh Class B or C) or hepatic dysfunction (ALT or AST \\> 2× upper limit of normal \\[ULN\\], or total bilirubin \\> 1.5× ULN)\n* Active hepatitis B (HBsAg positive with HBV-DNA indicating active viral replication), active hepatitis C (HCV antibody positive with HCV-RNA indicating active viral replication), positive syphilis screen, known HIV infection, or positive HIV test\n* Confirmed or treated endocarditis, sepsis, or active infection requiring antibiotic treatment within 30 days prior to surgery\n* Requirement for aortic dissection repair, complex congenital heart surgery, emergency surgery, or life-saving surgery\n* History of malignant tumor, solid tumor, metastatic tumor, or hematological malignancy within the past 5 years\n* Prior organ transplantation or current use of immunosuppressive agents\n* Any condition that may conflict with or contraindicate the use of intravenous vasodilator therapy\n* Prior adverse reaction to nesiritide (recombinant BNP)\n* Participation in any other clinical trial within 30 days prior to surgery\n* Pregnant or breastfeeding women\n* Any other condition that, in the judgment of the investigator, renders the participant unsuitable for study participation",{"count":269,"type":22},694,[142],"Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious perioperative complication, independently associated with prolonged hospitalization, increased mortality, and progression to chronic kidney disease. Despite advances in surgical techniques and postoperative care, no widely accepted pharmacological prevention strategy exists.\n\nRecombinant human brain natriuretic peptide (rhBNP) exerts vasodilatory, diuretic, and natriuretic effects, reduces cardiac preload and afterload, and has demonstrated safety and efficacy in treating congestive heart failure. Preliminary studies suggest rhBNP may reduce postoperative serum creatinine, increase urine output, and improve renal outcomes; however, large-scale randomized controlled evidence is lacking.\n\nThe PROTECT-CS trial is a multicenter, prospective, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of perioperative continuous intravenous rhBNP infusion (0.01 μg\u002Fkg\u002Fmin for 48 ± 2 hours) for prevention of AKI in high-risk patients undergoing cardiac surgery with cardiopulmonary bypass. A total of 694 participants will be enrolled across 7 centers in China.",[273,274,29],"AKI - Acute Kidney Injury","Cardiac Surgical Procedures",[276,277,278,279,280,281,282,283,284,285],"Recombinant human brain natriuretic peptide","rhBNP","Nesiritide","Acute kidney injury","Cardiac surgery","Cardiopulmonary bypass","Renal protection","Randomized controlled trial","Cardiac surgery-associated acute kidney injury","CSA-AKI","2026-05-29",{"date":253,"type":35},{"date":289,"type":22},"2026-05-01",{"date":291,"type":22},"2029-07-31",{"name":293,"class":294},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100570077","phase-3-nitric-oxide-for-reduced-intensive-support-in-cardiac-surgery-with-cardiopulmonary-bypass-100570077","NCT06702553","Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass","Effect of Inhaled Nitric Oxide on Major Adverse Events Requiring Intensive Life Support in Adults Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Phase III, Double-Blind, Multicenter, Randomized Controlled Trial (Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass, the NORISC Trial)","NORISC","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Elective cardiac or aortic surgery requiring CPB\n3. Without history of previous open heart surgery.\n\nExclusion Criteria:\n\n1. Immediate emergency cardiac surgery;\n2. Cardiac surgery that requires deep hypothermic circulatory arrest;\n3. Planned cardiac surgery for congenital heart disease repair;\n4. Planned for heart transplatation\n5. Ongoing heart failure or low output syndrome already on intensive support (IABP, ECMO, left ventricular assist device such as impella, mechanical ventilation), left ventricular ejection fraction of \\\u003C 30% or comparable, equivalent preoperative conditions\n6. Already accepted or currently on inhaled NO therapy or inhaled\u002Faerosolized prostacyclin in the week prior to the enrollment;\n7. Endstage kidney disease with estimated glomerular filtration rate (eGFR) \\\u003C 15 ml\u002Fmin or already on renal replacement surgery.\n8. Hemophilia A or B\n9. Other terminal stage of chronic disease with life expectancy less than 1 year per evaluation and adjudication of the attending physicians.",{"count":304,"type":22},3650,[306],"PHASE3","Cardiac surgery is a procedure that is commonly performed worldwide. Despite these technological advances, cardiac surgery remains a high-risk surgery. Among post-operative complications, acute kidney injury, respiratory failure, myocardial infarction, and stroke as well as cognitive dysfunction are significant causes of mortality in patients undergoing and following cardiac surgery. Inhaled nitric oxide (NO) therapy as a selective pulmonary vasodilator in cardiac surgery has been one of the most significant pharmacological advances in managing pulmonary hemodynamics and life threatening right ventricular dysfunction and failure. In addition, newer applications show greater promise of inhaled NO as a therapy in the area of cardiac surgery associated acute kidney injury and ischemia reperfusion. However, this remarkable expectation to inhaled NO has experienced a roller-coaster ride with high hopes and nearly universal demonstration of physiological benefits but disappointing translation of these benefits to harder clinical outcomes, like mortality. Most of our understanding on the iNO field in cardiac surgery stems from small observational or single center randomized trials, which failed to ascertain strong evidence base. As a consequence, there are only week clinical practice guidelines on the field and only European expert opinion for the use of iNO in routine and more specialized cardiac surgery. There is need for a large multicenter randomized controlled study to confirm the administration of iNO as an effective weapon for the battle against life threatening complication in high risk cardiac surgical patients.\n\nIn a previous meta analysis with 27 studies included, we demonstrated that inhaled nitric oxide (NO) could reduce the duration of mechanical ventilation and reducing biomarkers of organ injury and clinical signs of organ dysfunction in cardiac surgery under cardiopulmonary bypass (CPB) , but had no significance in the ICU stay, hospital stay, and mortality. This may be attributed to the small sample size of the most included studies (of the 27 studies included, 20 studies with sample size less than 100) and heterogeneity in timing, dosage and duration of iNO administration. Well-designed, large-scale, multicenter clinical trials are needed to further explore the effect of iNO in improving postoperative prognosis in cardiovascular surgical patients.\n\nWe are planning a large multicenter controlled randomized trial to demonstrate that inhaled nitric oxide can reduce composite outcome of death and Major Adverse Events (MAEs), including need for intensive supports due to heart failure, low cardiac output sydrome, or renal failure, respiratory failure, etc., and myocardial infarction, stroke, and sepsis at 30 days after surgery from 20% to 16% in patient undergoing cardiac surgery with cardiopulmonary bypass.\n\nIf the hypothesis had been proved and validated, the results of this study can provide strong evidence for guidelines to facilitate the routine use of iNO in all cardiopulmonary bypass assisted cardiac procedures with 31,800 postoperative outcomes improved per year in US and in China.",[309,57,29,310],"Nitric Oxide","Adult Patients Undergoing Cardiovascular Surgery With Cardiopulmonary Bypass",[309,312,313,64,314,315],"cardiopulmonary bypass","major adverse events","complications","Organ protection","2026-05-26",{"date":286,"type":35},{"date":319,"type":35},"2025-05-19",{"date":321,"type":22},"2029-03-31",{"name":323,"class":42},"Xijing Hospital",3,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":332,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":352,"leadSponsor":353,"locationsCount":43},"100637399","unilateral-ventilation-on-cardiopulmonary-bypass-during-cardiac-surgery-100637399","NCT07612709","Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery","Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery in Patients at Increased Risk for Severe Postoperative Pulmonary Complications","Inclusion Criteria:\n\n* Patients at increased risk for postoperative pulmonary complications\n* Major elective cardiac surgery\n* Prolonged duration of cardiopulmonary bypass\n* Patients older than 65 years of age\n* Informed consent\n\nExclusion Criteria:\n\n* Emergency\n* Urgent procedures\n* Patients with implanted pacemakers\n* Patients with internal cardioverter\u002Fdefibrillators\n* Decompensated cardiac disease\n* Pulmonary disease\n* Recent pneumonia\n* Need for temporary perioperative mechanical support\n* Patients not willing to participate\n* Treatment with inhaled nitric oxide","65 Years",{"count":334,"type":22},45,[25],"This study investigates if single lung ventilation on cardiopulmonary bypass can mitigate postoperative lung water accumulation determined by lung ultrasound in the ventilated lung as compared to the non-ventilated lung in patients at high-risk for developing severe pulmonary complications after cardiac surgery.",[338,29,339,340,341,342,343,344,345,346,347,348],"Lung Protective Ventilation","High-risk Cardiac Patients","Lung Ultrasound","Lung Water Assessment","Pulmonary Complications in Surgical Patients","Single-lung Ventilation","Chest X-ray for Clinical Evaluation","Electrical Impedance Tomography (EIT)","Lung Compliance","Oxygenation Indices","Biomarkers of Vascular Endothelial Injury","2026-05-24",{"date":286,"type":35},{"date":257,"type":22},{"date":291,"type":22},{"name":354,"class":42},"Medical University of Vienna",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":43},"100385235","neutrophil-phenotypic-profiling-and-acute-lung-injury-in-patients-after-cardiopulmonary-bypass-cpb-100385235","NCT04296071","Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)","Inclusion Criteria:\n\n* Are \\\u003C 12months of age\n* Scheduled for cardiac surgical needing CPB\n* Preoperative SpO2 \\> 90%\n\nExclusion Criteria:\n\n* Lack of parental (or legal guardian's) consent\n* Preoperative SpO2 \\\u003C 90%\n* Preoperative oxygen therapy","12 Months",{"count":363,"type":22},56,"Acute lung injury (ALI) following cardiopulmonary bypass (CPB) is a serious complication, often prolonging the length of stay in ICU and potentially dealing to mortality. The objective of this study is to assess the mechanism of CPB-mediated acute lung injury in pediatric patients.",[366,29],"Lung Injury","2026-05-13",{"date":231,"type":35},{"date":370,"type":35},"2022-10-14",{"date":372,"type":22},"2027-12",{"name":374,"class":42},"Sophia Koutsogiannaki",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":43},"100637397","perioperative-vericiguat-in-patients-undergoing-cardiovascular-surgery-100637397","NCT07594509","Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery","A Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Perioperative Vericiguat in Patients Undergoing Cardiovascular Surgery","Inclusion Criteria:\n\n* Aged 18 to 80 years, any sex;\n* Scheduled to undergo cardiovascular surgery at the study centers, including coronary artery bypass grafting (CABG), heart valve replacement\u002Frepair, and great vessel surgery;\n* Preoperative evaluation indicates a high risk of heart failure or confirmed cardiac dysfunction;\n* Systolic blood pressure (SBP) \\>= 100 mmHg;\n* Expected to complete the 6-month postoperative follow-up;\n* Signed written informed consent by the patient or their authorized representative.\n\nExclusion Criteria:\n\n* Current use of other sGC stimulators or phosphodiesterase type 5 (PDE-5) inhibitors (e.g., sildenafil, tadalafil);\n* Severe hypotension (symptomatic hypotension or resting SBP \\\u003C 90 mmHg);\n* Severe hepatic or renal dysfunction (Hepatic: Child-Pugh class C, or ALT\u002FAST \\> 3 times the upper limit of normal; Renal: eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m\\^2, or requiring chronic dialysis);\n* Malignant tumors, severe hematological diseases, or severe malnutrition (albumin \\\u003C 25 g\u002FL);\n* Known allergy to vericiguat or placebo components;\n* Pregnant or lactating women, or those planning to become pregnant during the study period;\n* Currently participating in other interventional clinical trials;\n* Moderate to severe cognitive impairment without a fixed guardian, unable to cooperate with treatment and follow-up;\n* Confirmed severe infection, sepsis, or septic shock preoperatively.","80 Years",{"count":384,"type":22},600,[25],"The purpose of this study is to evaluate the efficacy and safety of perioperative vericiguat in patients undergoing cardiovascular surgery. Patients at high risk of heart failure or with confirmed cardiac dysfunction will be randomly assigned to receive either vericiguat plus standard of care or standard of care alone. The primary objective is to determine whether perioperative administration of vericiguat can reduce (I) the Incidence of Early Postoperative Hemodynamic Deterioration or Clinically Significant Myocardial Injury; (II) Incidence of Major Sterile Inflammation-Related Organ Injuries (MSIRI), and the incidence of Major Adverse Cardiovascular Events (MACE) within 12 months after surgery.",[388,29],"Cardio Vascular Disease",[390],"cardiovascular","2026-05-11",{"date":393,"type":35},"2026-05-18",{"date":395,"type":22},"2026-05-31",{"date":397,"type":22},"2030-12-31",{"name":399,"class":42},"Nanjing Medical University",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":382,"enrollmentInfo":407,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":423,"leadSponsor":425,"locationsCount":43},"100632045","effect-of-hypothermia-on-bis-and-psi-correlation-during-cardiopulmonary-bypass-100632045","NCT07508579","Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass","Effect of Hypothermia on the Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) During Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Age ≥18 years\n* Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery\n* Planned use of general anesthesia\n* Written informed consent\n\nExclusion Criteria:\n\n* Preexisting neurological disease\n* Use of medications affecting Electroencephalography (e.g., antiepileptics)\n* Severe hepatic dysfunction\n* Emergency surgery\n* Inadequate signal quality for anesthesia depth monitoring",{"count":408,"type":22},60,"The goal of this observational study is to evaluate whether hypothermia affects the relationship between electroencephalography-derived indices during cardiac surgery in adult patients undergoing cardiopulmonary bypass.\n\nThe main questions it aims to answer are:\n\nDoes the correlation between Bispectral Index (BIS) and Patient State Index (PSI) change between normothermic and hypothermic phases during cardiopulmonary bypass? How do BIS and PSI values change in response to decreasing body temperature?\n\nParticipants will:\n\nUndergo standard general anesthesia for elective on-pump coronary artery bypass surgery Be monitored simultaneously with BIS and PSI devices during surgery Have data recorded at predefined temperature-based time points during cardiopulmonary bypass",[29,411,412],"Hypothermia; Anesthesia","Depth of Anesthesia Monitoring",[414,415,416,57,417,418,419],"Bispectral Index","Patient State Index","Processed EEG","Hypothermic CPB","Depth of Anesthesia","Intraoperative Monitoring","2026-05-05",{"date":391,"type":35},{"date":289,"type":35},{"date":424,"type":22},"2026-12-31",{"name":426,"class":42},"Sakarya University",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":451,"leadSponsor":453,"locationsCount":43},"100635198","antithrombin-as-a-predictor-of-heparin-resistance-in-cardiac-surgery-with-cardiopulmonary-bypass-100635198","NCT07549568","Antithrombin as a Predictor of Heparin Resistance in Cardiac Surgery With Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Age ≥18 years\n* Planned cardiac surgery with cardiopulmonary bypass\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Emergency cardiac surgery\n* Ongoing antithrombin supplementation prior to surgery\n* Known severe congenital coagulation disorder affecting interpretation of outcomes\n* Severe liver failure\n* Missing key data required to define heparin resistance (e.g., missing heparin dose or ACT values)",{"count":434,"type":22},300,"This study aims to investigate whether the level of antithrombin (AT) in the blood before cardiac surgery can predict how well patients respond to heparin, a medication used to prevent blood clotting during surgery with a heart-lung machine (cardiopulmonary bypass).\n\nHeparin requires antithrombin to work effectively. Some patients have lower levels of antithrombin, which may result in reduced response to heparin, a condition known as heparin resistance. This can lead to difficulties achieving adequate anticoagulation during surgery and may require additional medication or adjustments in treatment.\n\nIn this study, an additional blood sample will be taken after anesthesia induction but before the administration of heparin. No changes will be made to the patient's treatment or care. Clinical data, including laboratory values, heparin dosing, and surgical outcomes, will be collected from routine medical records.\n\nThe goal is to identify a clinically useful antithrombin threshold that can help detect patients at risk of heparin resistance. This may improve patient safety, optimize treatment strategies, and reduce unnecessary use of antithrombin therapy in the future.",[437,57,29],"Heparin Resistance",[439,440,441,442,443,281,280,444,445,446],"Antithrombin","Antithrombin III","Heparin resistance","Activated clotting time","ACT","Anticoagulation","Heparin response","Predictive biomarker","2026-04-28",{"date":449,"type":35},"2026-05-04",{"date":253,"type":22},{"date":452,"type":22},"2028-05-01",{"name":210,"class":42},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":462,"maxAge":19,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":467,"conditions":468,"keywords":477,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":43},"100630322","phase-1-influence-of-lung-volume-optimization-maneuver-on-cardiac-output-and-lung-compliance-in-ventilated-children-with-congenital-heart-disease-undergoing-surgical-repair-100630322","NCT07486167","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair","Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Mechanics in Children With Congenital Heart Disease","ILOCO-CHD","Inclusion Criteria:\n\n* Inclusion Criteria\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.","0 Days",{"count":189,"type":22},[465,466],"PHASE1","PHASE2","The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass.\n\nThe primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function.\n\nSecondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.",[469,29,470,471,472,473,474,475,476,57],"Congenital Heart Disease","Mechanical Ventilation","Peep Titration in Lung Protective Ventilation","Positive End-expiratory Pressure (PEEP)","Lung Volume","Lung Mechanics","Children","Hemodynamic Changes",[478,479,480,481],"cardiopulmonary interactions","end-expiratory lung volume","electrical impedance tomography","PEEP titration","2026-04-26",{"date":484,"type":35},"2026-04-30",{"date":486,"type":22},"2026-09-01",{"date":488,"type":22},"2028-12-31",{"name":490,"class":42},"Charite University, Berlin, Germany",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":499,"maxAge":19,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":501,"briefSummary":502,"conditions":503,"keywords":506,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":43},"100607835","phase-1-influence-of-personalized-lung-volume-optimization-maneuver-on-lung-function-and-cardiac-performance-in-children-100607835","NCT07193719","Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children","Influence of a Personalized Lung Volume Optimization Maneuver on Lung Aeration and Cardiac Performance in Mechanically Ventilated Children","ILOCO","CHD study:\n\nInclusion Criteria\n\n* congenital heart disease\n* surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* single ventricle physiology\n* ECMO\u002FVAD\n* \\\u003C36weeks of gestational age\n* chronic lung disease\n* Endotracheal tube leak \\> 15%\n* lack of informed consent from parents.\n\nECMO study Inclusion Criteria\n\n* patients with respiratory failure on ECMO or at risk for ECMO\n* invasive ventilation\n\nExclusion Criteria:\n\n\\- severe lung hypoplasia or interstitial lung disease","0 Years",{"count":189,"type":22},[465,466],"The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in\n\n1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and\n2. study) in children with severe respiratory failure at risk for or need for ECMO.\n\nThe main questions it aims to answer are:\n\nMain hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve:\n\n* cardiac performance\n* lung function\n\nDoes it make a difference in:\n\n* length of ventilation\n* ventilation\u002Fperfusion mismatch of the lung\n* need for vasopressor support?\n\nMain hypotheses of ECMO study:\n\nDoes a LVOM in children\u002Finfants with severe respiratory failure \u002FARDS\n\n* improve lung compliance and gas exchange\n* facilitate lung protective ventilation according to PALICC-2 guidelines\n* improve lung aeration and V\u002FQ-matching assessed with EIT\n\nDoes it make a difference in\n\n* need for ECMO\n* duration of ECMO runs\n* hemodynamics stability",[469,29,57,470,472,473,474,476,475,504,505],"ARDS","ECMO",[478,479,481,504,505,312],"2026-04-05",{"date":509,"type":35},"2026-04-09",{"date":511,"type":35},"2025-12-05",{"date":513,"type":22},"2027-12-20",{"name":490,"class":42},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":4},"100604034","comparison-of-milrinone-and-epinephrine-on-tapse-100604034","NCT07144267","Comparison of Milrinone and Epinephrine on TAPSE","Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial","Milrinone","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status II \\& III\n* Age between 18 and 70 years\n* Both Gender\n* Body mass index less than 40 kg\u002Fm2\n* Ejection fraction of \\>40%\n* Tricuspid annular plane systolic excursion (TAPSE) \\\u003C 1.7cm\n\nExclusion Criteria:\n\n* Patient refusal.\n* Preoperative RV impairment\n* Pulmonary hypertension (estimated pulmonary artery systolic pressure \\> 50 mmHg)\n* Patients with any contraindications to Transesophageal echocardiography (TEE)\n* Redo or Re-exploration surgery\n* Patients with chronic kidney disease (serum creatinine \\> 1.5 mg\u002F dl)\n* Patients with chronic liver disease (child pugh B and C)","70 Years",{"count":525,"type":22},102,[25],"Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.",[529,29],"Cardiac Anaesthesia",[531,532],"Cardiopulmonary bypass (CPB) -Tricuspid annular plane systolic excursion (TAPSE)-","Epinephrine - Milrinone","2026-02-23",{"date":535,"type":35},"2026-02-25",{"date":537,"type":22},"2026-03-01",{"date":539,"type":22},"2028-03-30",{"name":541,"class":42},"Mansoura University",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":565,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":582},"100537589","phase-2-intravenous-fish-oil-based-lipid-emulsion-to-enhance-recovery-in-high-risk-cardiac-surgery-patients-100537589","NCT06279793","Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients","Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial - A Randomized, Placebo-controlled Trial -","MODIFY CSX","Inclusion Criteria:\n\n1. Written informed consent prior to study participation\n2. Adult patients (≥ 18 years)\n3. Patients scheduled to undergo elective cardiac surgery with the use of CPB, who are defined as high risk based on having (i) one of the following surgical procedures: valvular heart surgery only, CABG, combined valve and CABG, multiple valve surgeries, combined cardiac procedures, aortic surgical procedures (aortic arch and\u002For descending aorta; aortic valve+ascending aorta) and (ii) at least one of the following additional risk factors: (a) a high perioperative risk profile, defined as predicted operative mortality of ≥8% (EuroSCORE II), (b) age ≥70, (c) Clinical Frailty Score 4 or more, (d) urgent surgery (defined as to be performed within 24-48 hours after admission), (e) left ventricular ejection fraction \\\u003C35%\n\nExclusion Criteria:\n\n1. Known hypersensitivity to fish oil\u002Ffish products or egg protein\n2. Pregnancy or lactation period\n3. Previous history of chronic atrial fibrillation, atrial flutter and\u002For atrial tachyarrhythmia\n4. Inability or unwillingness of individual to give written informed consent\n5. Not expected to survive an additional 48 hours from screening evaluation\n6. Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated \"Do not Resuscitate\" \\[DNR\\] acceptable)\n7. Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma\n8. Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)\n9. Enrolment in anyinterventional trial within the last 30 days\n10. Already receiving FO-containing medical nutrition products\n11. Severe malnutrition (as defined by the BMI \\\u003C18.5)\n12. Severe liver dysfunction defined by Child Pugh Class C.\n13. Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR \\\u003C30ml\u002Fmin)\n14. Known severe coagulation disorder",{"count":551,"type":22},550,[466],"The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy.\n\nA total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil\u002Fkg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.",[121,555,556,29,557,558,559,560,561,562,563,564],"Coronary Artery Bypass Grafting (CABG)","High Risk Patients","Elective Cardiac Surgery","Valvular Heart Surgery","Multiple Valve Surgeries","Combined Cardiac Procedures","Aortic Surgical Procedures","Adult Patients ≥ 18 Years","Combined Valve and CABG","Combined Cardiac and Aortic Surgical Procedures",[566,567,568,569,570,571,572],"intensive care unit","elective cardiac surgery","fish oil","medical nutrition therapy","atrial fibrillation","atrial flutter","atrial tachycardia","2026-02-19",{"date":533,"type":35},{"date":576,"type":35},"2024-02-15",{"date":578,"type":22},"2030-09",{"name":580,"class":581},"GCP-Service International West GmbH","INDUSTRY",10,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":602,"leadSponsor":604,"locationsCount":606},"100622998","gls-in-difficult-cpb-weaning-100622998","NCT07390903","GLS in Difficult CPB Weaning","Global Longitudinal Strain as a Predictor of Difficult Separating From Cardiopulmonary Bypass","Inclusion Criteria\n\n* Age \\> 18 years.\n* Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB).\n* Provided written informed consent to participate.\n* Eligible surgical procedures include:\n\n  * Isolated mitral valve replacement or repair.\n  * Isolated aortic valve replacement or repair.\n  * Isolated coronary artery bypass grafting (CABG).\n  * Combined valve and CABG surgery.\n  * Multiple valve replacement or repair.\n  * Surgery involving the ascending aorta or aortic arch.\n\nExclusion Criteria\n\n* Emergency cardiac surgery.\n* Redo cardiac surgery.\n* Contraindications to transesophageal echocardiography (TEE).\n* Critical preoperative conditions, including:\n\n  * Ongoing inotropic drug therapy.\n  * Preoperative mechanical circulatory support (e.g., IABP, ECMO, VAD).\n  * Requirement for mechanical ventilation.\n  * Preoperative atrial fibrillation.",{"count":591,"type":22},213,"The goal of this observational study is to learn whether global longitudinal strain (GLS), measured by echocardiography, can predict difficulty separating from cardiopulmonary bypass (CPB) in adults undergoing elective cardiac surgery.\n\nThe main questions it aims to answer are:\n\n* Can preoperative GLS measurement predict difficult separation from CPB?\n* Are GLS values associated with outcomes such as intensive care unit (ICU) stay, hospital stay, cardiac biomarkers, or 30-day mortality?\n\nParticipants will:\n\n* Undergo standard cardiac surgery requiring CPB\n* Have echocardiographic assessments (TTE before and after surgery)\n* Have their recovery and outcomes monitored, including ICU and hospital stay, postoperative labs, and survival within 30 days",[29,111,594,595,596,597],"Heart Valve Diseases","Echocardiography","Intraoperative Complications","Postoperative Complications (Cardiopulmonary)","2026-02-01",{"date":600,"type":35},"2026-02-05",{"date":600,"type":22},{"date":603,"type":22},"2026-08-30",{"name":605,"class":294},"Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital",2,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":625,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":43},"100620224","safety-and-performance-evaluation-of-cpb-venous-and-arterial-cannulas-100620224","NCT07354841","Safety and Performance Evaluation of CPB Venous and Arterial Cannulas","A Two Phases Clinical Investigation Consisting of a Pre-Market, Pilot, Interventional, Not Randomized, Monocentric Investigation to Evaluate the Safety of PVC Arterial Cannula and PVC Venous Cannula (Class III Medical Devices) Intended to be Used During Cardiopulmonary Bypass (CPB) Procedure Followed by a Pre-Market, Pivotal, Interventional, Randomized, Non- Inferiority, Monocentric Investigation to Confirm the Safety and Evaluate the Performance of the Same Cannulas","Inclusion Criteria:\n\n1. Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;\n2. Female and male patients aged ≥ 18;\n3. Body weight between 60 and 120 kg;\n4. Body surface area (BSA) between 1.5 and 2.5 m2;\n5. Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and\u002For aortic valve surgery).\n\nExclusion Criteria:\n\n1. Emergency cases;\n2. Re-do cardiac surgery procedure;\n3. Diabetes mellitus;\n4. Hematologic diseases or history of thrombophilia;\n5. Pregnancy or breastfeeding;\n6. Concomitant major cardiac procedures;\n7. Active malignant\u002Fmetastatic neoplasm of any type;\n8. Presence of pneumothorax and\u002For pulmonary emphysema;\n9. Significant central nervous system injury;\n10. Current intracranial hemorrhage;\n11. Immunosuppression;\n12. Contraindication for therapeutic anticoagulation (e.g., heparin);\n13. Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;\n14. Abnormal or pathological cannulation site;\n15. Uncontrolled active bleeding;\n16. Awaiting transplantation;\n17. Requiring preoperative extracorporeal membrane oxygenation;\n18. Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study.\n19. Patient is taking part in another interventional clinical study;\n20. Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.",{"count":189,"type":22},[25],"This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety. Phase 2 is a pivotal study aimed at confirming safety and evaluating efficacy through comparison with Medtronic cannulas (control group).\n\nThe results will be compared for non-inferiority with those obtained using the control group cannulas.",[57,618,29,619,620,621,622,623,624],"Heart Surgery","Coronary Surgery","Aortic Valve Surgery","Cannulation","Venous Cannulation","Arterial Cannulation","Coronary Surgery With Cardiopulmonary Bypass",[626,627,628,29,57,629,630,631,620,619,632,633,634,635,636,637,638,639],"Arterial Cannula","Venous Cannula","Extracorporeal Circulation","Medical Device","Device Safety","Device Performance","Two Phases clinical investigation","Monocentric Study","Two Phases Study","Serious Adverse Events (SAE)","CVP","NIRS","Venous Cannula Drainage Pressure","Arterial Cannula Reinfusion Pressure","2026-01-12",{"date":642,"type":35},"2026-01-21",{"date":644,"type":35},"2025-10-21",{"date":646,"type":22},"2026-09-30",{"name":648,"class":581},"Eurosets S.r.l.",{"id":650,"slug":4,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":23,"phases":658,"briefSummary":659,"conditions":660,"keywords":663,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":606},"100527420","NCT06147531","Delayed Cold-Stored Platelets -PLTS-1","A Clinical Comparison of Cold-stored and Room Temperature-stored Allogeneic Platelet Transfusions in Bleeding Adult Cardiac Surgery Patients - A Randomized Multicentre Pilot Study (PLTS-1 Study)","PLTS-1","Inclusion Criteria:\n\nAdult (≥18 years old) patients undergoing elective cardiac surgery with CPB will be eligible for inclusion if they are planned to undergo at least moderately complex surgery or have a preoperative platelet count ≤150,000 x106\u002FL (this is a group at high risk of requiring platelet transfusions post-CPB).\n\nModerately complex index surgery is defined as:\n\n1. repair\u002Freplacement of more than one valve;\n2. aorta (root\u002Fascending\u002Farch) replacement;\n3. any combination of coronary artery bypass grafting, valve repair\u002Freplacement, or aorta (root\u002Fascending\u002Farch) replacement; or\n4. re-do procedures consisting of a repair or revision of a prior cardiac intervention.\n\nExclusion Criteria:\n\nPatients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient:\n\n1. has a congenital or acquired hemostatic disorder (including platelet refractoriness due to anti-platelet and anti-human leukocyte antigen \\[HLA\\] antibodies) and\u002For requires specially matched platelets (including patients with anaphylaxis to blood due to Immunoglobulin A \\[IgA\\] deficiency),\n2. has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used,\n3. is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery,\n4. is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid \\[ASA\\]),\n5. refuses allogeneic blood products,\n6. has a known pregnancy,\n7. has already enrolled in this study,\n8. is enrolled in another interventional clinical trial where routine care and management are altered,\n9. has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or\n10. has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).",{"count":657,"type":22},150,[466],"PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.",[661,662,29,57],"Platelets","Bleeding",[664,665,666,667],"Blood Platelets","Cardiac surgical procedure","Blood Preservation\u002FMethods","Blood Preservation\u002FAdverse Effects","2025-12-22",{"date":670,"type":35},"2025-12-29",{"date":672,"type":35},"2024-06-05",{"date":674,"type":22},"2026-12",{"name":676,"class":42},"University Health Network, Toronto",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":683,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":23,"phases":686,"briefSummary":687,"conditions":688,"keywords":693,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":698,"lastUpdatePostDateStruct":699,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":43},"100613511","heart-lung-machine-impact-of-the-priming-solution-on-acid-base-balance-electrolytes-and-outcome-on-patients-undergoing-cardiac-surgery-100613511","NCT07267546","Heart-Lung Machine: Impact of the Priming Solution on Acid-Base Balance, Electrolytes and Outcome on Patients Undergoing Cardiac Surgery","Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)","PRIMEII","Inclusion Criteria:\n\n* Patients 18 years and above\n* Undergoing coronary artery bypass graft (CABG) surgery as single surgery\n* Undergoing aortic valve replacement (AVR) as single surgery (AtriClip is allowed)\n* Given consent to participate, both verbal and written\n\nExclusion Criteria:\n\n* Subnormal heart function (defined as an ejection fraction \\\u003C45%), and no signs of heart failure (edema).\n* Body weight \\\u003C60 kg or \\>120 kg\n* Preoperative hemoglobin \\\u003C120 g\u002FL,\n* Subnormal kidney function (defined as GFR \\\u003C30 ml\u002Fmin),\n* Blood sodium outside normal range (135-145 mmol\u002Fl),\n* Need of acute surgery\n* AVR due to aortic valve insufficiency\n* Changes in operating method or addition of intraoperative procedures.",{"count":189,"type":22},[25],"Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. The circuit in our institution requires 1100 mL to be filled.\n\nThe body has several mechanisms with the purpose to maintain its state of balance. When a large amount of clear solution suddenly enters the blood stream this balance can be altered. The goal of this clinical trial is to investigate different priming solutions in the heart-lung machine circuit. The main questions it aims to answer are:\n\nHow do different priming solutions alter the acid-base balance, osmolality and electrolytes which reflects the body's water balance for patients undergoing cardiac surgery with the use of heart-lung machine?\n\nThere will be 4 different groups:\n\n1. Ringer-Acetate, 1100 mL \u002F no addition\n2. Ringer-Acetate, 1100 mL + 80 mmol sodium chloride (NaCl)\n3. Ringer-Acetate, 1100 mL + 160 mmol NaCl\n4. Plasmalyte, 1100 mL \u002F no addition Blood samples will be taken before, during and after surgery, post operative day 1 and 4 to analyze acid-base balance, electrolytes, and plasma osmolality. Urine output and hydration status will also be collected until post operative day 1. After 3 months, a blood sample will be taken for analysis of electrolytes and kidney function.",[689,690,691,692,29],"Acid Base Imbalance","Osmolality Disturbance","Crystalloid Solutions","Electrolyte Changes",[312,694,695,696,697],"priming solution","acid base balance","electrolytes","plasma osmolality","2025-12-04",{"date":511,"type":35},{"date":701,"type":35},"2025-09-01",{"date":703,"type":22},"2026-11-01",{"name":705,"class":42},"Region Skane",{"id":707,"slug":708,"hasResults":12,"nctId":709,"briefTitle":710,"officialTitle":711,"acronym":4,"eligibilityCriteria":712,"healthyVolunteers":12,"sex":18,"minAge":332,"maxAge":713,"enrollmentInfo":714,"targetDuration":4,"studyType":23,"phases":715,"briefSummary":716,"conditions":717,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":722,"lastUpdatePostDateStruct":723,"startDateStruct":724,"completionDateStruct":726,"leadSponsor":728,"locationsCount":43},"100613326","phase-4-remimazolam-vs-midazolam-to-reduce-delirium-in-adults-65-undergoing-cpb-valve-surgery-100613326","NCT07265128","Remimazolam vs Midazolam to Reduce Delirium in Adults ≥65 Undergoing CPB Valve Surgery","Effect of Remimazolam on Delirium After Cardiac Surgery: Randomized Controlled Trial With Midazolam","Inclusion Criteria:\n\n* Patients aged 65 years or older undergoing heart valve surgery involving cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Emergency surgery, Surgery involving total arch replacement, History of remimazolam anaphylaxis, History of major neurocognitive disorder, Alcohol or substance dependence\u002Fabuse, Major depressive disorder, Schizophrenia, Participation in other clinical studies that may affect outcomes, Inability to provide informed consent due to illiteracy, foreign language barrier, or cognitive impairment.","99 Years",{"count":434,"type":22},[142],"\"Postoperative delirium is a common and serious complication following cardiac surgery, particularly among older adults who require intensive care. Its incidence is reported to range between 20% and 70% after cardiopulmonary bypass (CPB), and has been associated with prolonged hospitalization, increased medical costs, higher morbidity and mortality, and long-term cognitive decline. Benzodiazepines are frequently used during anesthetic induction in cardiac surgery due to favorable hemodynamic stability, although multiple clinical guidelines have recommended limitation of benzodiazepine exposure because of concerns for delirium. However, robust clinical evidence in cardiac surgery remains limited.\n\nMidazolam is currently the most commonly administered benzodiazepine in this setting, though metabolism through hepatic pathways and accumulation of active metabolites may increase the risk of postoperative delirium, especially in older patients and those with organ dysfunction. Remimazolam, a recently approved benzodiazepine, undergoes rapid hydrolysis by plasma esterases and demonstrates predictable pharmacokinetic properties with a markedly shorter context-sensitive half-time compared to midazolam. These pharmacologic features suggest a potentially reduced impact on postoperative delirium risk. Despite this rationale, no randomized controlled trial has evaluated the effect of remimazolam versus midazolam on delirium after CPB-assisted valve surgery.\n\nThis randomized double-blind controlled trial aims to determine whether remimazolam reduces the incidence of postoperative delirium compared with midazolam in patients aged ≥65 years undergoing valve surgery with CPB. Eligible participants will be randomized in a 1:1 ratio to receive either remimazolam or midazolam for anesthetic induction according to a computer-generated allocation sequence. All other anesthetic management will follow standardized institutional protocols, including depth of anesthesia monitoring. Delirium assessment will be performed three times daily in the intensive care unit using Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC) and twice daily on the ward using 3-Minute Diagnostic Interview for CAM (3D-CAM) for four postoperative days.\n\nThe primary endpoint is the incidence of delirium within four postoperative days. Key secondary outcomes include in-hospital or 30-day mortality and a composite of major postoperative complications. A total of 300 patients (150 per group) will be enrolled to provide 90% statistical power to detect the hypothesized difference in delirium risk between groups, accounting for a 10% dropout rate. Findings from this study are expected to provide high-quality evidence regarding the comparative impact of remimazolam and midazolam on postoperative delirium and may inform anesthetic strategy selection in high-risk cardiac surgical populations.\"",[718,719,720,29,721],"Delirium","Critical Illness","Aged","Benzodiazepines","2025-11-23",{"date":698,"type":35},{"date":725,"type":22},"2025-12",{"date":727,"type":22},"2027-09",{"name":729,"class":42},"Yonsei University"]