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COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Bordeaux
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In plain words

What the trial is, and whether it could suit you

Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own

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📋 Eligibility rules (as published)
Inclusion Criteria: Adult patients (≥18 yr) affiliated or beneficiary of a social security scheme and undergoing on-pump cardiac surgery at high risk for bleeding with autotranfusion indication defined as: * Primary or redo combined cardiac procedures (2 valves or more, valve(s) and coronary artery bypass grafting(s)) * Primary or redo ascending aorta surgery * Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or more grafts using the internal mammary artery * Free, informed and written consent signed by the participant and the investigator Exclusion Criteria: * Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days for prasugrel, and within one preoperative hour for cangrelor) * Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours for therapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylactic LMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparin Sepsis * Malignant tumor * Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency disorders, AIDS) * Emergency cardiac surgery * Heart transplantation * Implantation or patients under ventricular assist device (VAD) * Patients with two or more previous sternotomy * Surgery procedure requiring circulatory arrest and/or profound hypothermia (\<32°C) * Active infective endocarditis * Cardiac surgical procedure for benign or malignant cardiac tumors * Patients with known acquired or constitutional coagulopathy requiring specialist management * End stage renal disease * Preoperative haemoglobin level less than 10 g/dL * Preoperative platelet count \< 100 G/L * Persons participating in another interventional research including a period of exclusion that is still ongoing * Pregnant or breastfeeding women * Persons placed under judicial protection * Patients deprived of liberty
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What it tests

  • Autotransfusion
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Where

10 sites
CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire
Bordeaux, France
HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation
Bron, France
CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve
Montpellier, France
CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque
Nantes, France
Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale
Paris, France
Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation
Paris, France
Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation
Paris, France
CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV
Rennes, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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