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Recruiting NCT06405516

NCT06405516 Platelet Function After Cardiac Surgery.

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Clinical Trial Summary
NCT ID NCT06405516
Status Recruiting
Phase
Sponsor Insel Gruppe AG, University Hospital Bern
Condition Platelet Dysfunction
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2024-06-12
Primary Completion 2025-12-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Autologous blood cell salvage with in-house deviceAutologous cell salvage with i-Sep SAME device

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 40 participants in total. It began in 2024-06-12 with a primary completion date of 2025-12-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Intraoperative cell salvage is commonly used in cardiac surgery to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation situation after cardiac surgery. There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are retransfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the cardiac surgery population. The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.

Eligibility 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).

Contact & Investigator

Central Contact

Fabio Barattiero, MD

✉ fabio.barattiero@insel.ch

📞 004131632111

Principal Investigator

Gabor Erdoes, MD

STUDY CHAIR

University of Bern

Frequently Asked Questions

Who can join the NCT06405516 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Platelet Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06405516 currently recruiting?

Yes, NCT06405516 is actively recruiting participants. Contact the research team at fabio.barattiero@insel.ch for enrollment information.

Where is the NCT06405516 trial being conducted?

This trial is being conducted at Bern, Switzerland.

Who is sponsoring the NCT06405516 clinical trial?

NCT06405516 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Gabor Erdoes, MD at University of Bern. The trial plans to enroll 40 participants.

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