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Platelet Function After Cardiac Surgery. (PLFICS)

I

Insel Gruppe AG, University Hospital Bern

Status

Enrolling

Conditions

Platelet Dysfunction

Treatments

Device: Autologous cell salvage with i-Sep SAME device
Device: Autologous blood cell salvage with in-house device

Study type

Interventional

Funder types

Other

Identifiers

NCT06405516
BASEC 2023-D0074

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Patients undergoing cardiac surgery using the conventional cell saver device
Active Comparator group
Treatment:
Device: Autologous blood cell salvage with in-house device
Patients undergoing cardiac surgery using the cell saver device
Experimental group
Treatment:
Device: Autologous cell salvage with i-Sep SAME device

Trial contacts and locations

1

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Central trial contact

Gabor Erdoes, MD; Fabio Barattiero, MD

Data sourced from clinicaltrials.gov

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