CompletedNot Applicable

Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME

France304 participantsStarted 2021-06-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient

Timeframe: up to 1 week

Trial details

NCT IDNCT06766032

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-01