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RECRUITING

NCT06425614

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

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.

Official title: Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2024-07-15

Completion Date

2026-02-15

Last Updated

2025-06-29

Healthy Volunteers

Conditions

On-pump Cardiac Surgery High Risk for Bleeding Autotransfusion

Interventions

PROCEDURE

Autotransfusion

ANTIFIBRINOLYTIC THERAPY : tranexamic acid as antifibrinolytic therapy : dose after anaesthesia induction followed by continuous intravenous infusion until end INTRAOPERATIVE MANAGEMENT : * Routine monitoring : five lead-ECG, pulse oximeter, non-invasive arterial pressure will be instituted. A peripheral venous catheter and an arterial catheter * The general anaesthesia : * propofol and Remifentanil or sufentanil both simultaneously administered . * monitoring of the bispectral index * Triple lumen central venous catheter * Heparinization (300 UI/kg) * Aortic and right auricular cannulations TRANSFUSION PROTOCOL : * During CPB, PRBC transfusion if necessary * In the postoperative period if necessary In bleeding patients: The perioperative use of blood products will be managed according to results of conventional haemostasis tests or viscoelastic point of care tests when available in the center.

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

Locations (10)

CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire

Bordeaux, France, 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

CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale

Strasbourg, France

CHU Toulouse, Hôpital Rangueil, Service Anesthésie

Toulouse, France

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (10)