Badanie porównujące nową metodę ratowania krwi pacjenta podczas operacji serca

ClinicalTrials.gov➕ 12.06.2026Status: Trwa rekrutacjaFaza: Nie dotyczy

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

W skrócie

Badanie sprawdza, czy nowe urządzenie do odzyskiwania krwi pacjenta podczas operacji serca - które ratuje zarówno czerwone krwinki, jak i płytki krwi - lepiej zapobiega krwotokom niż tradycyjne urządzenia ratujące tylko czerwone krwinki. Pacjenci biorący udział w badaniu otrzymają swoją własną krew, którą urządzenie wyczyści i zwróci do organizmu. Badanie ma pokazać, czy ta metoda skraca pobyt w szpitalu i zmniejsza potrzebę transfuzji obcej krwi u osób poddawanych operacjom serca.

Oryginalny opis (angielski)

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.

Metadane badania

NCT ID
NCT06425614
Status
Trwa rekrutacja
Faza
Nie dotyczy
Sponsor
University Hospital, Bordeaux
Data startu
15.07.2024
Choroby
On-pump Cardiac Surgery, High Risk for Bleeding, Autotransfusion
Kraje
France