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

Recruiting now · Not applicable

Conditions studied: On-pump Cardiac Surgery, High Risk for Bleeding, Autotransfusion

In brief

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 platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device. Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection.

Key facts

Study ID

NCT06425614

Run by

University Hospital, Bordeaux

People needed

570

Starts

2024-07-15

Expected to finish

2027-02-15

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque — Nantes, France (enrolling)
• CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve — Montpellier, France (enrolling)
• CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV — Rennes, France (enrolling)
• CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale — Strasbourg, France (enrolling)
• CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire — Bordeaux, France, France (enrolling)
• CHU Toulouse, Hôpital Rangueil, Service Anesthésie — Toulouse, France
• HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation — Bron, 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

Full record on ClinicalTrials.gov

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