Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and… (NCT06766032) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient