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NCT Number: NCT06405516

Platelet Function After Cardiac Surgery.

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.

Recruiting

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Key information

Conditions

Platelet Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Gabor Erdoes, MD PhD

CONTACT

[email protected]

0041316322726

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Autologous blood cell salvage with in-house device

Device

In addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood.

Autologous cell salvage with i-Sep SAME device

Device

In addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood.

Primary outcomes

  1. Platelet number

    Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)

    Platelet number as measured by flow cytometry after processing and retransfusion of the salvaged blood to the patient.

Secondary outcomes

  1. Platelet function measured by multiple electrode aggregometry

    Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)

    Platelet function, as measured by point-of-care test

  2. Platelet function measured by platelet activation markers (P-selectin)

    Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)

    Platelet function, as measured by point-of-care test

  3. Platelet function measured by platelet activation markers (GPIb and GPIIb)

    Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)

    Platelet function, as measured by point-of-care test

  4. Platelet function measured with viscoelastic point-of-care test (Clotpro)

    Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)

    Platelet function, measured by point-of-care test using ExTest und FibTest assays with viscoelastic point-of-care test device

  5. Platelet function measured with viscoelastic point-of-care test (ROTEM)

    Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)

    Platelet function, measured by point-of-care test using ExTEM und FibTEM assays with viscoelastic point-of-care test device

  6. Number of allogeneic blood products transfused

    Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)

    Number of allogeneic blood products used (red blood cell, fresh frozen)

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Barattiero, MD

CONTACT

[email protected]

004131632111

Gabor Erdoes, MD

CONTACT

[email protected]

004131632111

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University Hospital, Geneva
  • University of Zurich

Registry information

Official study title

Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.

Acronym: PLFICS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 8, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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