An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion. The objective is to evaluate whether platelet recovery provides better quality of hemostasis during and after surgery, improving transfusion savings, and whether it reduces postoperative complications and the length of stay in the intensive care unit and in the hospital.
° Primary outcome of the study : The primary outcome of the study is to compare the evolution of perioperative platelet count based on the type of blood recovery used, either SAME or Cell-Saver. The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient between the SAME and Cell-Saver groups. ° Secondary outcomes of the study: The secondary outcomes are to evaluate, from the preoperative period until day 28 postoperatively: * The post-operative platelet count between days 1 and 5 * The frequency of perioperative and postoperative transfusions, including the number and type of blood products transfused * The use of derivative medications (fibrinogen, prothrombin complex concentrates) * The volume of postoperative bleeding * The frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) * The length of stay in the intensive care unit and in the hospital * The frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents.
Study Type
OBSERVATIONAL
Enrollment
304
The Cell-saver device allows for red blood cell reinfusion during cardiac surgery.
The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery.
CHU de Nantes
Nantes, France
Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient
The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient in the Cell-saver group or in the SAME group.
Time frame: up to 1 week
Postoperative platelet
Postoperative platelet count between day 1 and day 5
Time frame: 5 days
Perioperative and postoperative transfusions
Frequency of perioperative and postoperative transfusions, number and type of blood products transfused from surgery (day 1) to 28 days after surgery
Time frame: 28 days
Derivative medications
Use of derivative medications (fibrinogen, prothrombin complex concentrates) from surgery (day 1) to 28 days after surgery
Time frame: 28 days
Postoperative bleeding
Volume of postoperative bleeding from surgery (day 1) to 28 days after surgery
Time frame: 28 days
Postoperative events
Frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) from surgery (day 1) to 28 days after surgery
Time frame: 28 days
Durations of stays
Duration of stays in the intensive care unit and in the hospital from surgery (day 1) to 28 days after surgery
Time frame: 28 days
Postoperative anemia
Frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents from surgery (day 1) to 28 days after surgery
Time frame: 28 days
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