[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extracorporeal-circulation-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extracorporeal-circulation-complications":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,77,104,136,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100476720","miecc-versus-conventional-cardiopulmonary-bypass-in-cardiac-surgery-miecs-100476720",false,"NCT05487612","MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)","Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial","MiECS","Inclusion Criteria:\n\n* All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest.\n\nExclusion Criteria:\n\n* Requirement for emergency or salvage operation.\n* Requirement for major aortic surgery (e.g. aortic root replacement).\n* Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products.\n* Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded).\n* Inability to give informed consent for the study (e.g. learning or language difficulties).","ALL","18 Years","85 Years",{"count":21,"type":22},1300,"ESTIMATED","INTERVENTIONAL",[25],"NA","MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.",[28,29,30],"Coronary Artery Disease","Aortic Valve Stenosis","Extracorporeal Circulation; Complications",[32,33,34,35,36],"Cardiopulmonary bypass","Extracorporeal circulation","Minimal invasive extracorporeal circulation","Coronary artery bypass grafting","Aortic valve replacement","RECRUITING","2026-03-27",{"date":40,"type":41},"2026-03-30","ACTUAL",{"date":43,"type":41},"2022-05-26",{"date":45,"type":22},"2029-03-31",{"name":47,"class":48},"Aristotle University Of Thessaloniki","OTHER",13,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100529899","pilot-study-on-ha380-column-use-in-critically-ill-patients-receiving-extracorporeal-support-100529899","NCT06179771","Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.","HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support for Acute Critical Illness; a Prospective, Randomised, Interventional, Feasibility, Pilot Study (HACEC)","HACEC","Inclusion Criteria\n\n* Consent obtained\n* Male or Female, aged 18 years - 65 years.\n* Admitted with a diagnosis of sepsis (according to sepsis-3 definition), trauma, ARDS of infectious or non-infectious aetiology, trauma or after major surgery\n* Need for extracorporeal support and specifically renal replacement therapy (RRT) and\u002For ECMO.\n* Vasopressor or inotropic therapy requirement at the time of RRT or ECMO support\n* Within 72 hours of requiring extracorporeal support\n* At least one of:\n* CRP \\> 100 mg\u002FL (in the absence of immunosuppressive therapy\u002Fimmunomodulation)\n* Lactate \\>2 mmol\u002FL\n\nExclusion Criteria\n\n* The participant may not enter the trial if ANY of the following apply:\n* Unable to obtain consent.\n* Expected to die in the next 24 hours.\n* Pre-existing chronic kidney disease - requiring dialysis \u002FeGFR \\\u003C 30ml\u002Fmin\u002F1.73m2\n* Pre-existing severe respiratory failure - e.g., requiring home oxygen\u002F home nebulisers\u002F poor exercise tolerance\n* Chronic heart failure - NYHA class III and above\n* Pregnancy\n* Requirement for immediate immune modulation e.g., plasma exchange, high dose steroids , IV immunoglobulins (does not include vasoplegic dose of steroids or immune modulation for COVID 19)\n* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.","65 Years",{"count":60,"type":22},40,[25],"Patients who are very ill either due to a severe infection, major organ injury, trauma or a major operation may require significant support with devices such as a dialysis machine for the kidneys or Extracorporeal Membrane Oxygenation (ECMO) for the heart and lungs. This is often due to a reaction of the body to the insult which is termed inflammation. The investigators would like to assess if the use of a device that can remove the agents driving this reaction can lead to a quicker recovery form the illness. The device is a blood filter called HA380 and it would be connected to either the dialysis machine or the ECMO circuit. The investigators want to assess the feasibility of conducting a study with the HA380 column. We will also evaluate if the use of the HA380 column has an effect on the time spent on dialysis or ECMO, time spent on the breathing machine, time spent requiring drugs to support blood pressure and time spent in the intensive care unit.",[64,65,66,30],"Acute Kidney Injury","ARDS","Inflammation","2026-02-27",{"date":69,"type":41},"2026-03-02",{"date":71,"type":41},"2024-09-02",{"date":73,"type":22},"2026-10-31",{"name":75,"class":48},"University Hospitals, Leicester",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":76},"100523425","dic-markers-and-thrombin-generation-parameters-in-patients-on-ecmo-support-a-pilot-study-100523425","NCT06095518","DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study","DIC-ECMO","Inclusion Criteria:\n\n* Age ≧ 18; AND\n* Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND\n* Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.\n\nExclusion Criteria:\n\n* Patients who are on central VA-ECMO support; OR\n* Patients with missing clinical data; OR\n* Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR\n* Post-operative admissions","80 Years",{"count":86,"type":22},50,"OBSERVATIONAL","To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.",[30,90],"Extracorporeal Membrane Oxygenation Complication",[92,93,94],"ECMO","Thrombosis","Haemorrhage","2025-07-21",{"date":97,"type":41},"2025-07-24",{"date":99,"type":41},"2023-05-30",{"date":101,"type":22},"2025-12-31",{"name":103,"class":48},"Queen Mary Hospital, Hong Kong",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":76},"100574086","evaluation-of-blood-and-cardiac-protein-o-glcnacylation-levels-in-cardiac-surgery-in-children-100574086","NCT06754709","Evaluation of Blood and Cardiac Protein O-GlcNAcylation Levels in Cardiac Surgery in Children","Evaluation of the Levels of O-GlcNAcylation of Cardiac and Blood Proteins in Paediatric Cardiac Surgery and Identification of Therapeutic Targets","CardiOGlcNAc","Inclusion Criteria:\n\n* Age from 0 to 17 years at the time of sampling\n* Children undergoing CEC for cardiac surgery\n* Signed bio-collection consent\n\nExclusion Criteria:\n\n* Children with an infection\n* Children with fever\n* Children with an immune deficiency\n* Children with autoimmune disease\n* Children with metabolic disease\n* Children with haematological diseases\n* Children with a genetic disease\n* Unsigned consent\n* Refusal by parents or child","17 Years",{"count":114,"type":22},300,"Cardiac surgery requires the use of extracorporeal circulation (ECC). Age-related differences in inflammatory response, the greater susceptibility of immature organ systems to injury and the larger ratio of extracorporeal circuitry to patient size make younger and smaller patients more vulnerable to organ injury. The main problem associated with ECC in neonates and infants is the duration of ECC due to heavier surgeries leading to a prolonged inflammatory state resulting in capillary leak syndrome, low cardiac output syndrome and organ dysfunction, resulting in higher morbidity and mortality. The means of limiting this inflammatory response remain limited. Future studies should aim to address new post-ECC prophylactic targets to improve myocardial and endothelial function. Cardiac metabolism is an important area of research because it plays a central role in maintaining cardiac function under stress. The study of O-GlcNAcylation could therefore be an interesting therapeutic target, given the beneficial role of its stimulation in acute stress situations, as demonstrated in sepsis.",[117,30,118,119],"Cardiac Surgery","Metabolism","Low Cardiac Output",[121,122,123,124,125,126],"cardiac surgery","extracorporeal circulation","metabolism","low cardiac output","O-GlcNAcylation,","systemic inflammatory response syndrome","2025-04-10",{"date":129,"type":41},"2025-04-13",{"date":131,"type":41},"2025-02-13",{"date":133,"type":22},"2035-01-31",{"name":135,"class":48},"Nantes University Hospital",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":145,"conditions":146,"keywords":152,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":76},"100576524","a-monitoring-system-based-on-the-multifactorial-dynamic-perfusion-index-to-predict-and-prevent-the-onset-of-postoperative-acute-kidney-injury-after-cardiac-surgery-based-on-a-dynamic-collection-of-hemodynamic-and-clinical-parameters-during-cardiopulmonary-bypass-100576524","NCT06786416","A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass","PEQUOD 2","Inclusion Criteria:\n\n* patients undergoing cardiac surgery with cardiopulmonary bypass\n* patients \\>18 years for WP1 and WP3; patients \\\u003C6 years and weight \\\u003C20 kg for WP2\n* willingness to participate and sign the informed consent\n\nExclusion Criteria:\n\n* chronic renal failure on dyalisis for WP1 and WP3\n* emergency surgery for all WP\n* refusal to partecipate",{"count":144,"type":22},800,"This project is based on a predictive alghorithm (Multifactorial Dynamic Perfusion Index-MDPI) already published and covered by a patent. The MDPI is based on a dynamic collection of 7 different variables during cardiopulmonary bypass (CPB) and provides a probability index for postoperative acute kidney injury. The study design is a multicenter observational prospective trial developed through 3 work packages, addressing (1) external validation of the MDPI in a series of 800 adult cardiac surgery patients collected in 2 Institutions (2) development of a novel MDPI to be applied in infants \\\u003C 20 kg undergoing cardiac surgery (200 patients) and (3) verification of of other possible outcomes that may be predicted by the MDPI. Since many of the predictive variables are modifiable by the perfusionist\u002Fanesthesiologist during CPB, it is a tool that allows therapeutic manouvres. Ultimately, the MDPI will be incorporated in a dedicated monitor to provide an on-line \"flight control\" during CPB. Work package 1 will be performed at Units 1 and 2; the parameters composing the MDPI will be collected using the existing CPB monitors that routinely measure the hematocrit, the oxygen delivery, the time of exposure to a pre-defined critical oxygen delivery, the mean arterial pressure, and the CPB duration. Blood lactates and transfusions will be manually inputed. The MDPI will be calculated off-line and tested for association and predictivity (discrimination and calibration) with respect to postoperative AKI defined according to the K-DIGO classification. Workpackage 2 is dedicated to infants, with the purpose of developing an MDPI dedicated to low-weight infants (I-MDPI). This will be develop in Unit 1 that performs congenital heart surgery. The same variables of the MDPI will be collected, plus additional variables specific for infants (blood to prime the oxygenator, plasma for the same purpose; venous oxygen saturation, and others). The variables being independently associated with AKI will enter a logistic regression equation that will be the basis for the I-MDPI. Workpackage 3 considers that AKI is associated with a prolonged mechanical ventilation time, prolonged stay in the intensive care unit and in the hospital; and mortality. Therefore, the MDPI may be predictive of other postoperative complications, apart from AKI, and even of mortality. Some of the factors included in the MDPI may directly (low hematocrit) or indirectly (prolonged CPB duration, excessive hemodilution, low mean arterial pressure) affect the hemostatic system and\u002For trigger packed red cells transfusions. Additionally, CPB itself is a determinant of a coagulophatic state with associated postoperative bleeding which, in turns, increases the mortality. The specific aim 3 is to confirm the hypothesis that the MDPI may be predictive of one or more of this non-AKI postoperative complications and of 30-days mortality. In the same series of work package and aim 1, these complications will be collected and the MDPI tested for predictive ability of each one of these complications and 30-days mortality. At present, the MDPI can only be calculated off-line, and this greatly limits its applicability. The last step of the aim 3 is based on the involvement of software experts and partnership with companies interested in including the MDPI into their existing monitors; as such, the MDPI patent would be given under licence of the existing patent owned by the IRCCS Policlinico San Donato.",[147,148,64,149,150,30,151],"Cardiac Diseases","Cardio-pulmonary Bypass","Adult Cardiac Surgery","Infants Cardiac Surgery","Perfusion; Complications",[153,154,121],"cardiopulmonary bypass","acute kidney injury","2025-01-15",{"date":157,"type":41},"2025-01-22",{"date":159,"type":41},"2024-09-18",{"date":161,"type":22},"2026-09",{"name":163,"class":48},"IRCCS Policlinico S. Donato",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":76},"100552797","inflammatory-response-and-oxidative-stress-in-cardiac-surgery-min-invasive-vs-conventional-extracorporeal-circulation-100552797","NCT06477757","Inflammatory Response and Oxidative Stress in Cardiac Surgery: Min. Invasive vs. Conventional Extracorporeal Circulation","Oxidative Stress and Systemic Inflammatory Response After Cardiac Surgery: Minimally Invasive Extracorporeal Circulation vs. Conventional Extracorporeal Circulation","Inclusion Criteria:\n\n* Patients undergoing elective isolated coronary artery bypass grafting (CABG) with the use of cardio-pulmonary bypass (CPB) through median sternotomy with central cannulation\n\nExclusion Criteria Before Enrollment:\n\n* refusal to participate in the study,\n* pregnant women,\n* patients with previous cardiac surgery (i.e., redo surgery),\n* emergency surgery,\n* patients with known allergy to any drugs used in the study protocol except cefazolin.\n\nExclusion Criteria After Enrollment:\n\n\\- Patients in whom intraoperative transesophageal echocardiogram (TEE) would show an atrial septal defect, where additional procedures would be needed intraoperatively or a conversion from MiECC to conventional extracorporeal circulation would be needed.","99 Years",{"count":173,"type":22},200,[25],"The goal of our research project is to measure and compare oxidative stress markers, and systemic inflammatory response in patients undergoing open heart surgery with either conventional or minimally invasive extracorporeal circulation as well as develop pharmacokinetic profiles of different oxidative stress markers for further research on inflammatory response after open heart surgery. The main questions our study aims to answer are :\n\n* Does the type of extracorporeal circulation affect the levels of different oxidative stress markers?\n* Can preoperative and postoperative oxidative stress marker levels be of prognostic values?\n* Do preoperative and postoperative oxidative stress markers correlate with the clinical outcomes in patients?\n\nResearchers will compare the effect of conventional and minimally invasive extracorporeal circulation on clinical outcomes, oxidative stress marker levels, and systemic inflammatory response.\n\nParticipants will be randomised into two groups (one undergoing arrested-heart surgery with the use of conventional extracorporeal circulation, and the second group undergoing arrested-heart surgery with the use of minimally invasive extracorporeal circulation) and laboratory data, oxidative stress markers, and clinical data will be collected until discharge.",[177,178,30],"Oxidative Stress","Systemic Inflammatory Response Syndrome",[117,180,32,177,178,181,182,183],"Minimally invasive extracorporeal circulation","Oxidative stress biomarkers","Malondialdehyde","Endocan","NOT_YET_RECRUITING","2024-06-25",{"date":187,"type":41},"2024-06-27",{"date":189,"type":22},"2024-07-29",{"date":191,"type":22},"2026-12-31",{"name":193,"class":48},"University Medical Centre Maribor"]