Cardiac Surgery Requiring Cardiopulmonary Bypass, Cardiac Surgery Under Extra Corporeal Circulation
Conditions
Keywords
cell-saver, auto-transfusion, platelet transfusion, blood saving techniques
Brief summary
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.
Detailed description
° 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.
Interventions
DEVICECELL-Saver
The Cell-saver device allows for red blood cell reinfusion during cardiac surgery.
DEVICESAME
The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery.
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled cardiac surgery under cardiopulmonary bypass with a predicted duration of more than 2 hours, or surgery of the aortic arch, redo surgery, multiple aorto-coronary bypasses (\>2), or combined surgery (valvular and coronary).
Exclusion criteria
* Pre-existing constitutional or acquired bleeding disorder (hemophilia A or B, von Willebrand disease, myelodysplastic/myeloproliferative syndrome) * Patients with sepsis, a malignant tumor at the surgical site, or contamination of recovered blood with biological fluids/antiseptics/distilled water/local antibiotics/hemostatic agents. * Organ transplantation and planned circulatory support in the preoperative period * Uni-bi-ventricular artificial heart * Reoperation in a patient already included in the study * Patient refusing blood transfusion * Pregnant women * Legally Protected adults
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient | up to 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative platelet | 5 days | Postoperative platelet count between day 1 and day 5 |
| Perioperative and postoperative transfusions | 28 days | Frequency of perioperative and postoperative transfusions, number and type of blood products transfused from surgery (day 1) to 28 days after surgery |
| Derivative medications | 28 days | Use of derivative medications (fibrinogen, prothrombin complex concentrates) from surgery (day 1) to 28 days after surgery |
| Postoperative anemia | 28 days | Frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents from surgery (day 1) to 28 days after surgery |
| Postoperative events | 28 days | Frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) from surgery (day 1) to 28 days after surgery |
| Durations of stays | 28 days | Duration of stays in the intensive care unit and in the hospital from surgery (day 1) to 28 days after surgery |
| Postoperative bleeding | 28 days | Volume of postoperative bleeding from surgery (day 1) to 28 days after surgery |
Countries
France
Outcome results
None listed