Brief 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.

Conditions

• On-pump Cardiac Surgery
• High Risk for Bleeding
• Autotransfusion

Intervention / Treatment

• Procedure: Autotransfusion

Primary Outcome Measures

• Perioperative bleeding (At the end of Day 1)
  The proportion of patients with clinically significant (moderate to massive) perioperative bleeding according to the Universal Definition for Perioperative Bleeding.

Countries

France

Locations and Investigators

• CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire, Bordeaux, France (Recruiting)
  • Alexandre Ouattara, MD, PhD
  • Antoine BEURTON
• HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation, Bron, France (Not yet recruiting)
  • Jean-Luc FELLAHI, MD, PhD
• CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve, Montpellier, France (Recruiting)
  • Philippe GAUDARD, MD
• CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque, Nantes, France (Recruiting)
  • Bertrand ROZEC, MD, PhD
• Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale, Paris, France (Not yet recruiting)
  • Aude Carillion, MD
• Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation, Paris, France (Not yet recruiting)
  • Sophie Provenchere, MD
• Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation, Paris, France (Not yet recruiting)
  • Bernard Cholley, MD, PhD
• CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV, Rennes, France (Recruiting)
  • Alexandre Mansour, MD
• CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale, Strasbourg, France (Recruiting)
  • Paul-Michel MERTES, MD, PhD
• CHU Toulouse, Hôpital Rangueil, Service Anesthésie, Toulouse, France (Not yet recruiting)
  • François Labaste, MD

Study Officials

• Alexandre Ouattara, MD, PhD (Principal Investigator) — University Hospital, Bordeaux