NCT06425614View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

570

Participants

Timeline

Start Date

July 15, 2024

Primary Completion Date

February 15, 2026

Study Completion Date

February 15, 2026

Conditions
On-pump Cardiac SurgeryHigh Risk for BleedingAutotransfusion
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."

Trial Locations (10)

31400

NOT_YET_RECRUITING

CHU Toulouse, Hôpital Rangueil, Service Anesthésie, Toulouse

33076

RECRUITING

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

34295

RECRUITING

CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve, Montpellier

35033

RECRUITING

CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV, Rennes

44093

RECRUITING

CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque, Nantes

67091

RECRUITING

CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale, Strasbourg

69677

NOT_YET_RECRUITING

HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation, Bron

75651

NOT_YET_RECRUITING

Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale, Paris

75877

NOT_YET_RECRUITING

Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation, Paris

75908

NOT_YET_RECRUITING

Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation, Paris

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER