[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ischemia-reperfusion-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ischemia-reperfusion-injury":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,77,103,133,164,188,225,253,277,303,330,354],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100605616","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-bx-001n-in-preventing-cardiac-surgery-associated-acute-kidney-injury-csa-aki-and-major-adverse-kidney-events-make-100605616",false,"NCT07164833","A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)","Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a Clinical Trial of BX-001N to Prevent From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE)","Inclusion Criteria:\n\n1. 19 to 90 years of age\n2. Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)\n3. Body weight ≥ 30 kg\n4. Participants with vital signs within the following ranges\n\n   * Temperature : 35.0\\~37.5°C\n   * Blood pressure : Systolic blood pressure(SBP) 100\\~160 mmHg, Diastolic blood pressure(DBP) \\\u003C 100 mmHg\n   * Pulse : 50\\~100 bpm (regardless of drug use)\n5. Willing to comply with the schedule and sign the informed consent\n6. Participants with moderate renal impairement\n\nExclusion Criteria:\n\n1. Participants scheduled for emergent or salvage cardiac surgery\n2. Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)\n3. Participants at risk of bleeding\n4. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease\n5. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery\n6. Recipient of a solid organ or bone marrow transplantation\n7. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device\n8. Active systemic bacterial, viral, or fungal infection\n9. History of HIV\n10. Positive serology test for HAV, HBV, HCV or Syphilis\n11. Participants with impaired liver function due to cirrhosis, or those with 2x UNR blood levels of ALP, AST, or ALT, or with total bilirubin levels outside the normal range\n12. Uncontrolled hypertension\n13. History of congenital immunodeficiency\n14. Genetic disorder with severe and abnormal bilirubin metabolism\n15. Participants deemed unsuitable for the study in the discretion of the investigator\n16. History of malignancy\n17. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury\n18. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents\n19. History of participation in other clinical trials within 30 days\n20. Presence of a do-not-resuscitate order or life expectancy of \\\u003C 3 months\n21. Female subjects of childbearing potential\n22. Male subjects and their spouse\u002Fpartner are not willing to use appropriate contraception, or if their spouse\u002Fpartner is pregnant, breastfeeding or has a plan\n23. Poorly controlled type 2 diabetes mellitus\n24. New York Heart Association (NYHA) Class IV heart failure","ALL","19 Years","90 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events (MAKE) in approximately 50 participants.",[27,28],"Ischemia Reperfusion Injury","Cardiac Surgery Associated - Acute Kidney Injury","RECRUITING","2026-06-28",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2025-08-26",{"date":37,"type":21},"2028-04",{"name":39,"class":40},"Bilix Co.,Ltd.","INDUSTRY",8,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100644712","new-biomarkers-for-organ-viability-assessment-during-hypothermic-machine-perfusion-in-liver-transplantation-the-role-of-extemporaneous-histological-examination-100644712","NCT07674394","New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.","LOVE","Inclusion Criteria:\n\n1. Adult liver transplant recipients (≥18 years of age).\n2. Donor liver grafts from either Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD).\n3. Grafts undergoing hypothermic oxygenated perfusion (HOPE) (HOPE or D-HOPE) for a minimum duration of 1 hour prior to transplantation.\n4. Availability of two wedge liver biopsy samples: one pre perfusion and one post-perfusion.\n5. Grafts preserved using standard cold storage protocols and transported in ice-cold Servator C™ solution.\n6. Informed consent obtained from the recipient (or legal representative, where applicable) for the use of clinical and histological data for research purposes.\n\nExclusion Criteria:\n\n1. Inadequate or fragmented biopsy samples, preventing proper histological evaluation.\n2. Biopsy samples showing histological features of pre-existing chronic liver disease (e.g., cirrhosis, autoimmune hepatitis, chronic viral hepatitis).\n3. Liver grafts subjected to normothermic perfusion or other non hypothermic perfusion techniques.\n4. Organs undergoing experimental or non-standard perfusion protocols.\n5. Grafts from donors \\\u003C18 years of age.\n6. Recipient refusal or inability to provide informed consent.\n7. Technical failure during perfusion (e.g., incomplete perfusion due to device malfunction or vascular anomalies).\n8. Known malignancy in the donor with potential liver involvement, excluding donors with small incidentalomas as per standard guidelines.","18 Years",{"count":51,"type":21},150,[53],"NA","Liver transplantation is a life-saving treatment for patients with severe liver disease. Because of the shortage of donor organs, transplant centers increasingly use donor livers that may be more vulnerable to injury and dysfunction. To improve the quality of these organs before transplantation, many centers use hypothermic oxygenated machine perfusion (HOPE or D-HOPE), a technique that preserves the liver under cold, oxygenated conditions. However, there are currently no widely accepted methods to determine whether a liver is functioning well enough during this preservation process.\n\nThe purpose of this study is to investigate whether changes observed in liver tissue during hypothermic machine perfusion can help predict how well the transplanted liver will function after surgery. The study will compare liver biopsy samples collected before and after one hour of perfusion and will analyze biological markers released into the perfusion fluid, including markers of mitochondrial injury and inflammation.\n\nThe main question this study aims to answer is whether histological changes occurring during hypothermic perfusion, alone or in combination with biochemical biomarkers, can accurately predict liver graft viability and post-transplant outcomes. Researchers will also evaluate whether these data can be used to develop an artificial intelligence-based model to support clinical decision-making during organ preservation.\n\nA total of 150 adult liver transplant recipients receiving donor livers treated with HOPE or D-HOPE will be enrolled at three Italian liver transplant centers. Participants will be followed for 90 days after transplantation to assess liver graft function, graft survival, patient survival, and post-transplant complications.\n\nThe results of this study may improve the assessment of donor liver quality before transplantation and help clinicians make more informed decisions about organ use, ultimately increasing the safety and effectiveness of liver transplantation.",[56,57,58,59],"Liver Transplantation (LT)","Early Allograft Dysfunction","Primary Non-function","Ischemia-Reperfusion Injury",[61,62,63,59,64],"liver transplantation","Early Allograft Dysfunction (EAD)","Primary Non-Function (PNF)","Liver Graft Viability Assessment","NOT_YET_RECRUITING","2026-06-23",{"date":68,"type":33},"2026-06-29",{"date":70,"type":21},"2026-07",{"date":72,"type":21},"2029-06",{"name":74,"class":75},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies","OTHER",3,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100410901","osa-as-a-remote-ischemic-preconditioning-in-vascular-surgery-100410901","NCT04630535","OSA as a Remote Ischemic Preconditioning in Vascular Surgery","Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery","Inclusion Criteria:\n\n* patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)\n\nExclusion Criteria:\n\n* emergent surgery\n* aorto-bifemoral bypass using deep vein graft\n* re-operations\n* known OSA with CPAP treatment",{"count":85,"type":21},100,"OBSERVATIONAL","Ischemia and reperfusion (I\u002FR) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia.\n\nStudies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia.\n\nThe investigators hypothesize that I\u002FR injury will be less pronounced in patients who have OSA and that the extent of I\u002FR injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I\u002FR in patients undergoing elective AAA repair who do and do not have OSA.",[89,90,27],"Obstructive Sleep Apnea","Vascular Aneurysm",[92],"remote preconditioning","2026-04-22",{"date":95,"type":33},"2026-04-27",{"date":97,"type":33},"2020-11-01",{"date":99,"type":21},"2029-01-31",{"name":101,"class":75},"St. Anne's University Hospital Brno, Czech Republic",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":102},"100362920","phase-1-safety-and-efficacy-of-treprostinil-remodulin-in-reducing-ischemia-reperfusion-injury-during-kidney-transplantation-100362920","NCT04005469","Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation","A Phase I\u002FII Study Evaluating the Preliminary Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During De Novo Adult Kidney Transplantation","Inclusion Criteria:\n\n1. Male and female patients who will receive a deceased donor kidney aged 18 to 65 (inclusive) and are currently on the active transplant list at RIH.\n2. Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.\n3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Under the age of 18 years\n2. Difficult venous access\n3. BMI \\> 40 kg\u002Fm2\n4. Patients with severe clinical gastroparesis as determined by repeated vomiting\n5. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication\n6. Known or history of inflammatory bowel disease or bezoars\n7. History of diverticulitis, diverticular stricture, and other intestinal strictures\n8. Be receiving any investigational drug other than treprostinil or participating in any other investigational study\n9. Be receiving any prostanoid therapy to treat portopulmonary hypertension\n10. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil\n11. Have had a failed kidney transplant within the previous 180 days\n12. Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results\n13. Those with significant cardiovascular disease including treatment with inotropes\n14. If female, be pregnant or nursing (confirmed by urine test)\n15. Presence of a condition or abnormality that in the opinion of the Investigators that would compromise the safety of the patient or the quality of the data","75 Years",{"count":112,"type":21},20,[114,24],"PHASE1","The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.",[27,117],"Delayed Graft Function",[119,120,121,122,123],"Ischemia-reperfusion injury","kidney transplantation","prostacyclin","treprostinil","delayed graft function","2026-04-20",{"date":126,"type":33},"2026-04-23",{"date":128,"type":33},"2020-11-13",{"date":130,"type":21},"2028-06-30",{"name":132,"class":75},"Rhode Island Hospital",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":140,"minAge":49,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":144,"conditions":145,"keywords":151,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":102},"100613189","diep-flap-breast-reconstruction-perioperative-biomarkers-and-outcomes-100613189","NCT07263347","DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes","Prospective Observational Study of Perioperative Biomarkers and Outcomes in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction","Inclusion Criteria:\n\n1. Female, 18-70 years old.\n2. Clinically diagnosed with breast cancer and scheduled for immediate DIEP free-flap breast reconstruction after mastectomy.\n3. Conscious and able to understand and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n1. Severe cardiac, hepatic, or renal dysfunction or severe coagulopathy (e.g., NYHA class III-IV, Child-Pugh class C, eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n2. Preoperative active infection, autoimmune disease, or long-term use of immunosuppressants\u002Fanti-inflammatory drugs (e.g., corticosteroids).\n3. Pregnant or breastfeeding.\n4. Prior ipsilateral breast surgery or radiotherapy that may affect local blood circulation assessment.\n5. Any condition deemed unsuitable by the investigator (e.g., poor compliance).","FEMALE","70 Years",{"count":143,"type":21},30,"Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I\u002FR) injury. I\u002FR injury can happen when a flap has a period without blood flow (ischemia) and then blood flow returns (reperfusion). This process may trigger inflammation and oxidative stress and is associated with fat necrosis or partial flap loss.\n\n1\\. What is being studied\n\n1. The investigators will measure inflammation and oxidative stress markers in blood (for example, interleukin-6 \\[IL-6\\]) from before surgery through the first 72 hours after surgery.\n2. These data will help map the normal and abnormal patterns of recovery after surgery and may inform future approaches to monitoring and protecting flap tissue.\n3. No experimental drug or device is given to participants in this study. Separate animal studies are developing a near-infrared imaging and antioxidant nanomaterial (Mn\u002FQD-SAC); this is not used in participants here.\n\n2\\. Who can take part\n\n1. Women aged 18-70 scheduled for immediate DIEP flap breast reconstruction after breast cancer surgery.\n2. Key exclusions include severe heart, liver, or kidney disease; significant clotting problems; active infection or autoimmune disease; long-term use of immunosuppressants\u002Fanti-inflammatory drugs; pregnancy or breastfeeding; or other reasons judged by the research team.\n\n3\\. What will happen if you join\n\n1. After providing informed consent, participants will have blood drawn at five time points: pre-operative baseline (within 24 hours before surgery) and at 0, 6, 24, and 72 hours after surgery (about 10 mL each time; total \\~50 mL).\n2. Blood will be processed and stored under secure conditions and tested for inflammation and oxidative stress markers.\n3. The investigators will also record routine clinical information from the medical record (such as age, BMI, surgery duration, ischemia time, and clinical assessments of flap outcomes and complications).\n4. Participation does not change the participant's clinical care before, during, or after surgery.\n\n4\\. Risks and benefits\n\n1. Risks are those of standard blood draws: brief pain, bruising, bleeding, dizziness, and rare infection.\n2. There is no direct medical benefit to participants. Results may help improve understanding and future care for patients undergoing flap reconstruction.\n\n5\\. Privacy and data protection\n\n1. Samples and data will be coded without names. Identifying information is stored separately with restricted access.\n2. Research results are not routinely added to the medical record or returned to participants unless a finding has clear, actionable clinical significance and is approved by the ethics committee.\n\n6\\. Time commitment and costs\n\n1. All blood draws occur during the routine hospital stay. There is no additional follow-up required after discharge.\n2. There is no cost to participate.\n\n7\\. Voluntary participation Joining the study is voluntary. Participants may withdraw at any time without affecting their medical care.",[146,59,147,148,149,150],"Breast Neoplasms","Postoperative Complications","Wound Healing","Oxidative Stress","Inflammation",[152,153,154,119],"Deep inferior epigastric perforator (DIEP) flap","Autologous breast reconstruction","Free tissue transfer","2026-04-01",{"date":157,"type":33},"2026-04-03",{"date":159,"type":33},"2025-12-20",{"date":161,"type":21},"2026-10",{"name":163,"class":75},"Hubei Cancer Hospital",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":16,"minAge":172,"maxAge":141,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100544474","early-phase-1-vitamin-b6-on-exercise-pressor-reflex-on-leg-ischemia-reperfusion-100544474","NCT06369350","Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion","Effects of Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion","Inclusion Criteria:\n\n* Are males and females at least 21- 70 years of age (inclusive)\n* Capable of giving informed consent\n* Are of any race or ethnicity\n* Can communicate in English\n* Females may be on oral contraceptives but will be excluded if they are pregnant or lactating\n* Healthy Status as defined by the absence of evidence of any active or chronic disease as determined by the following:\n* a detailed medical history\n* complete physical examination (including vital signs)\n* a blood pressure that is within a safe range (\\\u003C150\u002F100mmHg)\n\nExclusion Criteria:\n\n* \\\u003C 21 years of age or \\> 70 years of age\n* Pregnant or nursing woman\n* Prisoners or institutionalized individuals unable to consent\n* Decisional impairment\n* Not able to communicate in English.\n* Current smoker\n* Have any clinically relevant history or the presence of metabolic (e.g., diabetes), respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or other disease or diseases that, in the opinion of the research team, exclude the subject from participation.\n* Presenting with a resting blood pressure of 150\u002F100 or higher\n* Taking any medications that affect vascular control or autonomic function (e.g. beta blockers, ACE inhibitors, calcium channel blockers, etc.)\n* Taking a multivitamin with B6, a B-complex vitamin, or vitamin B-6 at baseline, with a history of Parkinson's disease, and taking levodopa\n* Known allergy or hypersensitivity to Vitamin B6\n* Opioid Use Disorder or on opioid therapy\n* Subject has a recent drug or alcohol abuse history (less than 6 months) or is currently using or abusing excessive alcohol or drugs. Excessive alcohol will be defined as greater than 14 drinks per week. Use of recreational drugs in the past 6 months is also an exclusion.",true,"21 Years",{"count":143,"type":21},[175],"EARLY_PHASE1","In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients.",[27,178],"Peripheral Artery Disease","2026-03-16",{"date":181,"type":33},"2026-03-17",{"date":183,"type":21},"2027-12",{"date":185,"type":21},"2028-09",{"name":187,"class":75},"Milton S. Hershey Medical Center",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":195,"maxAge":110,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":102},"100515496","auricular-vagus-stimulation-and-stemi-100515496","NCT05992259","Auricular Vagus Stimulation and STEMI","Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction","Inclusion Criteria:\n\n* patients with STEMI who have signed an informed voluntary consent to participate in the study;\n* primary myocardial infarction;\n* treatment in the first 12 hours from the onset of pain syndrome;\n* primary PCI.\n\nExclusion Criteria:\n\n* acute heart failure III-IV;\n* bradyarrhythmias;\n* atrial fibrillation\u002Fflutter at the time of switching on;\n* Thrombolytic therapy at the prehospital stage;\n* a history of myocardial infarction;\n* PCI\u002Fcoronary artery bypass grafting (CABG) in the anamnesis.","40 Years",{"count":197,"type":21},300,[53],"At the moment, the invasive strategy for the infarct-associated coronary artery in patients with ST-segment elevation myocardial infarction (STEMI) necessary to save the myocardium and reduce the size of the necrosis zone remains the leading one. However, despite the high efficiency of providing medical care to patients with acute coronary syndrome (ACS), there remains a high mortality and disability of this group of patients. In this regard, the search for new drug and non-drug strategies for the treatment of patients with ACS is actively continuing. Over the past decade, it has been shown that transcutaneous vagus nerve stimulation (TENS) has a cardioprotective effect both in chronic heart failure and in coronary heart disease, improves cardiac function, prevents reperfusion injury, weakens myocardial remodeling, increases the effectiveness of defibrillation and reduces the size of a heart attack. One of the methods of noninvasive stimulation of the afferent fibers of the vagus nerve is percutaneous electrical stimulation of the auricular branch of the vagus nerve. However, further studies are needed to determine whether stimulation of the tragus can improve the long-term clinical outcome in this cohort of patients.",[201,202,27],"Vagus Nerve Stimulation","Acute Coronary Syndrome",[204,205,206,207,208,209,210,211,212,213,214],"auricular stimulation","auricular vagus nerve stimulation","transcutaneous vagus nerve stimulation (TENS)","vagus nerve stimulation (VNS)","acute coronary syndrome","myocardial ischemia reperfusion injury","ST-segment elevation myocardial infarction","coronary heart disease","acute myocardial infarction","mortality","atrial fibrillation","2025-06-17",{"date":217,"type":33},"2025-06-18",{"date":219,"type":33},"2022-09-01",{"date":221,"type":21},"2026-12-01",{"name":223,"class":224},"Bakulev Scientific Center of Cardiovascular Surgery","OTHER_GOV",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":232,"maxAge":110,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100560848","phase-2-a-trial-to-assess-efficacy-and-safety-of-ex-vivo-allograft-admin-of-icm012-solution-2-mgml-to-improve-its-function-in-recipients-of-dcd-kidneys-100560848","NCT06582485","A Trial to Assess Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg\u002Fml to Improve Its Function in Recipients of DCD Kidneys","A Randomized, Placebo-controlled, Double-blind Phase 2b Trial to Assess the Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg\u002FmL to Improve Allograft Function in Recipients of Donation After Circulatory Death Kidneys","Inclusion Criteria:\n\nTo be eligible for use in this trial, an allograft must meet the following criterion:\n\n1. Controlled DCD donors Maastricht category III from 55 to 75 years of age.\n\n   To be eligible to participate in this trial, a patient must meet all the following criteria:\n2. Available, personally signed and dated Informed Consent Form.\n3. Male or female chronic kidney disease (CKD) ≥ 18 years of age, on dialysis \\> 12 months, awaiting their first kidney transplantation.\n4. AB0-compatible, negative pre-transplantation Complement Dependent Cytotoxicity (CDC) and\u002For flow cytometric class I and II crossmatch, or negative virtual class I and II crossmatch, and no pre-existing donor specific antibodies (Mean Fluorescent Intensity under center specific cut-off for negative value).\n5. Completed vaccination program according to local standard practice or as deemed relevant by the investigator.\n\nExclusion Criteria:\n\nAn allograft that meets any of the following criteria will be excluded from use in this trial:\n\n1. Surgically induced injuries or anatomical vascular variations compromising ex vivo treatment and\u002For transplantation outcome, as judged by the investigator.\n2. DCDs with persistent and significant deterioration of kidney function (30% decrease in eGFR from baseline) and\u002For on dialysis within two (2) weeks prior to organ procurement and\u002For anuria \\> 12 hours before surgery.\n3. Extracorporeal membrane oxygenation treatment of the donor\n\n   A patient who meets any of the following criteria will be excluded from participation in this trial:\n4. If not tolerating\u002Feligible for thymoglobulin induction and tacrolimus or Cyclosporine A (CyA)-based maintenance immunosuppressants.\n5. Previously undergone any organ and\u002For cell transplantations.\n6. Positive CDC and or flow cytometric class I and\u002For II crossmatch, and\u002For positive virtual crossmatch.\n7. Highly sensitized patients defined by Panel Reactive Antibody (PRA) level equal or higher than 98%.\n8. AB0-incompatible deceased donor kidney transplantation.\n9. Pregnant or breast-feeding woman.\n10. Woman of child-bearing potential, not using an adequate contraceptive method.\n11. Prior participation in a clinical trial with (approved or non-approved) IMPs within 1 month prior to screening for this trial.\n12. Prior malignancy diagnosis ≤ 5 years, except for adequately treated basal cell, or squamous cell skin cancer, and carcinoma in situ, or judged as irrelevant by the investigator.\n13. Positive result for serum human immunodeficiency virus (HIV), active hepatitis B or C infection in pre-transplantation evaluation.\n14. History of severe drug allergy or hypersensitivity, or known hypersensitivity, or intolerance to any of the IMPs or its\u002Ftheir excipients.\n15. Concomitant severe conditions requiring treatment and close monitoring, as judged by the investigator.\n16. History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the trial, or influence the results or the patient's ability to participate in the trial.\n17. Unlikely to comply with trial procedures, restrictions, and requirements (e.g., caused by substance abuse, concurrent medical condition, etc.), as judged by the investigator.","55 Years",{"count":234,"type":21},200,[24,236],"PHASE3","Randomized (1:1), placebo controlled, double blind efficacy trial. 200 patients will be followed up for 12 months post transplantation. The primary endpoint will be Delayed Graft Function (DGF) defined as the requirement for dialysis within 7 days post transplantation.",[239,240],"Ischemia-reperfusion Injury","Kidney Transplant; Complications",[242,120,243,239],"Ex-vivo kidney allograft treatment","Transplant outcome","2025-03-31",{"date":246,"type":33},"2025-04-03",{"date":248,"type":21},"2025-09",{"date":250,"type":21},"2026-12",{"name":252,"class":40},"iCoat Medical AB",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":102},"100420121","phase-2-nad-augmentation-in-cardiac-surgery-associated-myocardial-injury-trial-100420121","NCT04750616","NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial","NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial","NACAM","Inclusion Criteria\n\n* Informed consent before any study-related activities.\n* Men or women \\>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes.\n\nProcedures include:\n\n* CABG\n* Aortic, mitral, tricuspid, or pulmonic valve replacement or repair\n* CABG with aortic, mitral, tricuspid, and\u002For pulmonic valve replacement\n\nRisk factors for surgery related to adverse cardiovascular outcomes include one or more of the following:\n\n* Valve surgery\n* eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2\n* Documented LVEF ≤ 35% within six months before surgery\n* Documented history of heart failure\n* Insulin-requiring diabetes\n* Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio)\n* Preoperative anemia (hemoglobin \\\u003C11g\u002Fdl for men and women)\n* History of prior CABG\n* Age ≥65\n\nExclusion Criteria\n\n* Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based)\n* Kidney transplant status\n* Off-pump cardiac surgery\n* ESRD\n* Emergent cardiac surgery\n* Pregnancy\n* Patient enrolled in competing research studies that may affect outcomes\n* Patients held in an institution by legal or official order",{"count":262,"type":21},304,[24],"A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery",[27,266,267],"Myocardial Injury","Acute Kidney Injury","2025-03-10",{"date":270,"type":33},"2025-03-12",{"date":272,"type":33},"2021-09-13",{"date":274,"type":21},"2025-06-30",{"name":276,"class":75},"Kaiser Permanente",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":102},"100439616","phase-2-hypertonic-lactate-after-cardiac-arrest-100439616","NCT05004610","Hypertonic Lactate After Cardiac Arrest","LATTE","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Sustained (\\> 20 minutes) return of spontaneous circulation (ROSC)\n* Comatose (GCS \\\u003C 9)\n* Time to ROSC \\> 15'\n\nExclusion Criteria:\n\n* Protected categories (Pregnant women)\n* Anticipated withdrawal of support within 24 hours\n* Traumatic cause of cardiac arrest\n* Body weight at admission \\> 120Kg",{"count":285,"type":21},125,[24],"The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.",[289,27,290],"Cardiac Arrest","Anoxic Brain Injury",[292,293],"sodium lactate","cerebral metabolism","2025-02-20",{"date":296,"type":33},"2025-02-21",{"date":298,"type":33},"2025-02-19",{"date":300,"type":21},"2028-05-15",{"name":302,"class":75},"Erasme University Hospital",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100556347","protecting-autologous-free-flaps-from-ischemiareperfusion-damage-with-cold-storage-100556347","NCT06523920","Protecting Autologous Free Flaps From Ischemia\u002FReperfusion Damage With Cold Storage.","Protecting Autologous Free Flaps From Ischemia\u002FReperfusion Damage With Cold Storage: a Randomized Controlled Trial","PAFFIRD","Inclusion Criteria:\n\n* Post-oncological mandible reconstruction through fibula free flap,\n* Post-oncological soft tissue reconstruction through ALT (Anterior Lateral Thigh) free flap in head and neck region\n* Post-oncological breast reconstruction through DIEP (Deep Inferior Epigastric Perforator) and PAP (Profunda femoris Artery Perforator) free flaps.\n\nExclusion Criteria:\n\n* Malnutrition\n* Malabsorption\n* Vasculitis\n* Pathologies of the connective tissue","85 Years",{"count":313,"type":21},90,[53],"Reconstructive microsurgery allows autologous transplantation of flaps. The procedure causes temporary ischemia. The absence of perfusion and the post-anastomosis reperfusion causes ischemia\u002Freperfusion (I\u002FR) damage and an increased percentage of flap complications associated with the longer duration of the ischemia time. In reconstructive surgery the utilization of preservation solution is very limited. The research hypothesis is that cold storage of free flaps might offer benefits. The present study is a RCT to evaluate the feasibility and safety of a cold preservation (using the UW solution) of the free flaps from I\u002FR damage in oncological microsurgical reconstructions. Blood perfusion will be intraoperatively evaluated through indocyanine green and SPY-DHI.\n\nMoreover, patients' outcomes will be evaluated postoperatively through clinical and radiological examinations, particularly focusing on somatosensory recovery and dental rehabilitation after mandibular reconstruction.",[27],[318,319,320],"free flap","microsurgery","cold ischemia","2024-07-23",{"date":323,"type":33},"2024-07-26",{"date":325,"type":21},"2024-08-01",{"date":327,"type":21},"2026-06-30",{"name":329,"class":75},"University of Cagliari",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":141,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":102},"100526959","safety-and-efficacy-of-remote-ischemic-conditioning-for-patients-taking-off-pump-coronary-artery-bypass-grafting-100526959","NCT06141525","Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting","Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE): A National, Multi-center, Randomized, Controlled, Open-label, Blinded-endpoint Trial","IMPROVE","Inclusion Criteria:\n\n* Diagnosed with coronary artery disease and require off-pump CABG surgery.\n* Between 18 and 75 years old;\n* Normal left ventricular systolic function (ejection fraction \\>40%) and left ventricular end-diastolic internal diameter (\\\u003C60 mm) in the cardiac ultrasound tests;\n* No or mild heart valve and great vessel abnormalities which do not require surgical intervention;\n* Participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent.\n\nExclusion Criteria:\n\n* Severe tissue injuries.\n* Myalgia, fractures and other peripheral vascular lesions.\n* Bypass graft being the radial artery.\n* Stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins.\n* Previous vagus nerve trunk dissection or vagus nerve block surgery.\n* Other surgical operations at the same time.\n* Patients with pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension and cardiogenic shock.\n* Severe coagulation abnormality or severe anemia.\n* Severe mental disorder.\n* Malignant tumors.\n* Pregnant or lactating.\n* Increased risk of treatment for patients, according to investigators.\n* Refuse to sign the informed consent form.",{"count":339,"type":21},648,[53],"Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis.",[343,344,59],"Coronary Artery Bypass Grafting","Remote Ischemic Conditioning","2024-07-10",{"date":347,"type":33},"2024-07-12",{"date":349,"type":33},"2023-11-22",{"date":351,"type":21},"2029-03-31",{"name":353,"class":75},"First Affiliated Hospital Xi'an Jiaotong University",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":110,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":369,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":4},"100358421","abdominal-regional-perfusion-in-donation-after-cardiac-death-for-multi-organ-transplantation-100358421","NCT03946852","Abdominal Regional Perfusion in Donation After Cardiac Death for Multi-Organ Transplantation","Recipient Criteria:\n\nInclusion Criteria- Indications for Liver transplant include decompensated Cirrhosis of any etiology Model for End-Stage Liver Disease (MELD) score \\> 15 with no contraindications to liver transplant as per conventional clinical practice.\n\nAcute or fulminant liver failure Advanced malignancy such as HCC, cholangiocarcinoma, neuroendocrine tumor, or other cancer meeting criteria for listing and exception points as per current clinical guidelines.\n\nExclusion Criteria-\n\n* Inadequate social support for liver transplant\n* Non-compliance with alcohol or narcotic cessation\n* Evidence of uncontrolled infection\n* Other untreated malignancy aside from those listed above\n* Physiologic evidence of frailty based on timed up and go, grip strength, 6 minute walk test, and cognitive testing.\n\nDonor Criteria:\n\nDCD donors offered via TGLN will be considered for assessment via abdominal regional perfusion based on the following parameters. These are in keeping with current criteria for abdominal organ donors.\n\n* Age: Up to 70 years of age within the initial evaluation period, with plans to expand to 75 y\u002Fo if initial results are favourable.\n* BMI: Donor BMI must be less than 30 for consideration\n* DCD donation criteria: Conventional criteria for DCD donation must be met, including no expectation for viable recovery, without meeting criteria for brain death, and expressed desire by family for organ donation.\n* Comorbidity: In the opinion of the on-call transplant surgeon, there should not be excessive comorbidity to exclude organ donation\n* Active infection: There should be no untreated infection.\n* Malignancy: Donors should have no evidence of active malignancy, or in the case of a treated malignancy there should be sufficient interval to rule out recurrence. In select cases, donors with tumors known to be indolent may be considered on a case by case basis.\n\nLiver transplant release Criteria:\n\nOne of the major advantages of ARP beyond reconditioning the organ prior to cold storage and transplant, is an opportunity to assess graft function in-situ prior to transplant. The existing literature supports the use of multiple readily available laboratory tests to evaluate graft function prior to transplant. Donor labs will be drawn every 30 minutes from the perfusion circuit to evaluate organ function.\n\n* Transaminase: Initial transaminases (AST and ALT) drawn at the start of perfusion must be less than 4 times the upper limit of normal and stay below this threshold throughout the reperfusion process to be considered for use with an absolute cut-off of 500\n* Lactate: Grafts will only be used if lactate levels do not rise during perfusion, ideal organs will have a decrease in serum lactate levels by 1.11 mmol\u002FL per hour\n* Macroscopic appearance: On clinical evaluation, there should be no evidence of fibrosis or cirrhosis and organs should not have a macroscopically steatotic appearance.",{"count":112,"type":21},[53],"The main purpose of this study is to increase the pool of organs available for donation by performing ARP to recondition donation after cardiac death (DCD) organs prior to transplantation. We will compare the outcomes of our ARP DCD liver transplants with historical data to determine the efficacy of this treatment compared to transplantation with standard DCD and donation after brain death (DBD) organs. We will also analyze biological samples from donors and recipients and compare them with outcome data in an effort to determine if any biological markers are able to predict the quality\u002Fsuccess of the grafts.",[364,27,365,366,367,368],"Liver Transplant; Complications","Cirrhosis","Liver Cancer","Liver Metastases","End Stage Liver Disease",[370,371,372,27],"abdominal regional perfusion","Donation after Cardiac Death","Liver Transplantation","2019-05-09",{"date":375,"type":33},"2019-05-13",{"date":377,"type":21},"2019-06",{"date":379,"type":21},"2026-06",{"name":381,"class":75},"London Health Sciences Centre"]