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

Last updated: June 25, 2025
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Treatment

Autotransfusion

Clinical Study ID

NCT06425614
CHUBX 2022/22
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 coronaryartery bypass grafting(s))

  • Primary or redo ascending aorta surgery

  • Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or moregrafts using the internal mammary artery

  • Free, informed and written consent signed by the participant and the investigator

Exclusion

Exclusion Criteria:

  • Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days forclopidogrel, 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 forVKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours fortherapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylacticLMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparinSepsis

  • Malignant tumor

  • Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment forsolid 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 specialistmanagement

  • 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 ofexclusion that is still ongoing

  • Pregnant or breastfeeding women

  • Persons placed under judicial protection

  • Patients deprived of liberty

Study Design

Total Participants: 570
Treatment Group(s): 1
Primary Treatment: Autotransfusion
Phase:
Study Start date:
July 15, 2024
Estimated Completion Date:
February 15, 2026

Study Description

The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets. A multicentre single-arm clinical feasibility and safety trial conducted by our group, using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89%, post-treatment hematocrit of 43% with an excellent washing performance. In addition, the device recovered 52% of platelets, that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry. By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC, this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products. It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality. Consequently, an improvement of postoperative outcomes and a decrease in intensive care unit (ICU) and hospital length of stay may be expected. The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. Consequently, a reduction of infectious complication may be also expected.

The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding (moderate to massive bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification).

Connect with a study center

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

    Bordeaux, 33076
    France

    Active - Recruiting

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

    Bron, 69677
    France

    Site Not Available

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

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque

    Nantes, 44093
    France

    Active - Recruiting

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

    Paris, 75651
    France

    Site Not Available

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

    Paris, 75877
    France

    Site Not Available

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

    Paris, 75908
    France

    Site Not Available

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

    Rennes, 35033
    France

    Active - Recruiting

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

    Strasbourg, 67091
    France

    Active - Recruiting

  • CHU Toulouse, Hôpital Rangueil, Service Anesthésie

    Toulouse, 31400
    France

    Site Not Available

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