Condition: On-pump Cardiac Surgery · High Risk for Bleeding · Autotransfusion · Sponsor: University Hospital, Bordeaux
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 …
This description comes directly from the study's public registry record.
Alexandre Ouattara, MD, PhD · 0557656866 · alexandre.ouattara@chu-bordeaux.fr
Antoine Beurton, MD · 0557677147 · antoine.beurton@chu-bordeaux.fr
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| CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire | Bordeaux, France, France | Recruiting |
| HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation | Bron, France | Not Yet Recruiting |
| CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve | Montpellier, France | Recruiting |
| CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque | Nantes, France | Recruiting |
| Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale | Paris, France | Not Yet Recruiting |
| Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation | Paris, France | Not Yet Recruiting |
| Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation | Paris, France | Not Yet Recruiting |
| CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV | Rennes, France | Recruiting |
| CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale | Strasbourg, France | Recruiting |
| CHU Toulouse, Hôpital Rangueil, Service Anesthésie | Toulouse, France | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06425614