Evaluating platelet function after cardiac surgery using different blood salvage devices
Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.
This study tests which of two blood-saving devices used during heart surgery does a better job of keeping platelets healthy to help patients recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06405516 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two different cell saver devices used during cardiac surgery to preserve platelet number and function. Intraoperative cell salvage is employed to minimize the need for donor blood transfusions, but the processing can lead to a loss of plasma, which is crucial for optimal coagulation. The researchers will compare the performance of an in-house device and the i-Sep SAME device in maintaining platelet integrity during the procedure. The goal is to determine which device better supports patient recovery post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old scheduled for elective high-risk cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients who have used anticoagulants or antiplatelet agents prior to surgery, except for aspirin, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved coagulation outcomes and reduced complications for patients undergoing cardiac surgery.
How similar studies have performed: While there is limited research specifically on platelet function preservation in cardiac surgery, similar studies on blood salvage techniques have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Elective high risk cardiac surgery with cardiopulmonary bypass usage * Cardiopulmonary bypass time \> 120 minutes * Written informed consent Exclusion Criteria: * Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin) * Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).
Where this trial is running
Bern
- Department of Anesthesiology and Pain Medicine — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Fabio Barattiero, MD
- Email: fabio.barattiero@insel.ch
- Phone: 004131632111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.