Clinical trial NCT06766032: Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME
Official title: Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver for Red Blood Cell Reinfusion and SAME for Red Blood Cell and Platelet Reinfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery Under Extra Corporeal Circulation
Cardiac Surgery Requiring Cardiopulmonary Bypass
Keywords: cell-saver
auto-transfusion
platelet transfusion
blood saving techniques
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient
timeFrame: up to 1 week
Secondary outcomes:
measure: Postoperative platelet
timeFrame: 5 days
measure: Perioperative and postoperative transfusions
timeFrame: 28 days
measure: Derivative medications
timeFrame: 28 days
measure: Postoperative bleeding
timeFrame: 28 days
measure: Postoperative events
timeFrame: 28 days
measure: Durations of stays
timeFrame: 28 days
measure: Postoperative anemia
timeFrame: 28 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes HU
name: Mickaël Vourc'h, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: