Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Locations1 site (Bern)
StatusRecruiting
StartedJune 12, 2024
Main results expectedDecember 1, 2025
Study endsJanuary 1, 2026
Registry record updatedJune 6, 2025
Trial IDNCT06405516 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.