Informations générales (source: ClinicalTrials.gov)

NCT06425614 En recrutement
Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial
Interventional
  • Hémorragie
N/A
University Hospital, Bordeaux (Voir sur ClinicalTrials)
juillet 2024
février 2026
15 septembre 2025
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Bichat Sophie Provenchere, MD Recrutement non commencé Contact (sur clinicalTrials)
AP-HP - Hôpital Europeen Georges Pompidou Bernard Cholley, MD, PhD Recrutement non commencé Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale - 67091 - Strasbourg - France Paul-Michel MERTES, MD, PhD En recrutement Contact (sur clinicalTrials)
CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire - 33076 - Bordeaux - France Alexandre Ouattara, MD, PhD En recrutement Contact (sur clinicalTrials)
CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve - 34295 - Montpellier - France Philippe GAUDARD, MD En recrutement Contact (sur clinicalTrials)
CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque - 44093 - Nantes - France Bertrand ROZEC, MD, PhD En recrutement Contact (sur clinicalTrials)
CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV - 35033 - Rennes - France Alexandre Mansour, MD En recrutement Contact (sur clinicalTrials)
CHU Toulouse, Hôpital Rangueil, Service Anesthésie - 31400 - Toulouse - France François Labaste, MD Recrutement non commencé Contact (sur clinicalTrials)
Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale - 75651 - Paris - France Aude Carillion, MD Recrutement non commencé Contact (sur clinicalTrials)
HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation - 69677 - Bron - France Jean-Luc FELLAHI, MD, PhD Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
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


- 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