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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell-Saver group | Patients for whom the Cell-saver device is used during cardiac surgery. |
| |
| SAME group | Patients for whom the SAME device is used during cardiac surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELL-Saver | Device | The Cell-saver device allows for red blood cell reinfusion during cardiac surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative platelet | Postoperative platelet count between day 1 and day 5 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients treated by the cardiac surgery department of Nantes University Hospital who undergo a cardiovascular procedure with cardiopulmonary bypass considered to be at high risk for bleeding; (prolonged cardiopulmonary bypass >2 hours, aortic arch surgery, history of redo cardiac surgery, combined surgery, multiple portocoronary bypasses). Procedures for which a perioperative blood recovery device (SAME or Cell-Saver) has been used, with the choice of the blood recovery technique at the discretion of the medical team.
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| Name | Affiliation | Role |
|---|---|---|
| Mickaƫl Vourc'h, MD-PhD | Nantes HU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44093 | France |
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| ID | Term |
|---|---|
| D057725 | Operative Blood Salvage |
| ID | Term |
|---|---|
| D020858 | Tissue and Organ Harvesting |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| SAME | Device | The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery. |
|
| 28 days |
| Derivative medications | Use of derivative medications (fibrinogen, prothrombin complex concentrates) from surgery (day 1) to 28 days after surgery | 28 days |
| Postoperative bleeding | Volume of postoperative bleeding from surgery (day 1) to 28 days after surgery | 28 days |
| Postoperative events | Frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) from surgery (day 1) to 28 days after surgery | 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 | 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 | 28 days |