Evaluating platelet function after cardiac surgery using different blood salvage devices
Official title: Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.
Run by Insel Gruppe AG, University Hospital Bern · NCT06405516 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | June 12, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | January 1, 2026 |
| Registry record updated | June 6, 2025 |
| Trial ID | NCT06405516 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old scheduled for elective high-risk cardiac surgery requiring cardiopulmonary bypass.
✕Probably not a fit
Patients who have used anticoagulants or antiplatelet agents prior to surgery, except for aspirin, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there is limited research specifically on platelet function preservation in cardiac surgery, similar studies on blood salvage techniques have shown promising results.
Who can join: the full rules
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 it's running
-
Department of Anesthesiology and Pain Medicine
Bern, Switzerland Recruiting
Study contacts
- Study coordinator: Fabio Barattiero, MD
- Email: fabio.barattiero@insel.ch
- Phone: 004131632111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using cangrelor to improve outcomes in patients with cardiogenic shock on ECMO
This study is testing if adding a medication called cangrelor can help patients in cardiogenic shock on ECMO have better outcomes while reducing bleeding risks during their treatment.
-
Observational study of blood clotting and bleeding disorders in Chinese patients
This study looks at blood clotting and bleeding problems in Chinese patients to see how common they are and what factors might affect them.
-
Understanding hemorrhage subtypes in perimesencephalic SAH and basilar artery perforator aneurysms
This study tests whether different bleeding patterns in pmSAH, including potential basilar artery perforator aneurysms, relate to patient outcomes using a patient-reported EQ-5D measure.
-
Pediatric Outpatient Health Data Cohort in Switzerland
This study tests the PROS-CH data-collection system in pediatric primary care to see if routine tools can build a useful cohort of children under age 2 for common health issues.
-
Pace-and-ablate strategy in atrial fibrillation: who benefits and long-term outcomes
This study looks at adults with atrial fibrillation who underwent AV node ablation with permanent pacing to see who develops pacing-induced problems and how they do long-term.
-
Left vs right subthalamic nucleus deep brain stimulation: how it changes thinking and mood in Parkinson’s
This study tests whether turning DBS on the left or the right side of the brain changes cognition and mood in people with Parkinson’s disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.