Platelet Function After Cardiac Surgery. (PLFICS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Platelet Dysfunction
• Intervention / Treatment: Device: Autologous blood cell salvage with in-house device; Device: Autologous cell salvage with i-Sep SAME device

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Barattiero, MD; Phone Number: 004131632111; Email: fabio.barattiero@insel.ch
• Study Contact Backup: Name: Gabor Erdoes, MD; Phone Number: 004131632111; Email: gabor.erdoes@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Anesthesiology and Pain Medicine
    • Contact: Gabor Erdoes, MD PhD; Phone Number: 0041316322726; Email: gabor.erdoes@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients undergoing cardiac surgery using the conventional cell saver device	Device: Autologous blood cell salvage with in-house 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.
Experimental: Patients undergoing cardiac surgery using the cell saver device	Device: Autologous cell salvage with i-Sep SAME 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet number	Platelet number as measured by flow cytometry after processing and retransfusion of the salvaged blood to the patient.	Perioperative period (begins on the day of surgery and ends on the day after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet function measured by multiple electrode aggregometry	Platelet function, as measured by point-of-care test	Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured by platelet activation markers (P-selectin)	Platelet function, as measured by point-of-care test	Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured by platelet activation markers (GPIb and GPIIb)	Platelet function, as measured by point-of-care test	Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured with viscoelastic point-of-care test (Clotpro)	Platelet function, measured by point-of-care test using ExTest und FibTest assays with viscoelastic point-of-care test device	Perioperative period (begins on the day of surgery and ends on the day after surgery)
Platelet function measured with viscoelastic point-of-care test (ROTEM)	Platelet function, measured by point-of-care test using ExTEM und FibTEM assays with viscoelastic point-of-care test device	Perioperative period (begins on the day of surgery and ends on the day after surgery)
Number of allogeneic blood products transfused	Number of allogeneic blood products used (red blood cell, fresh frozen)	Perioperative period (begins on the day of surgery and ends on the day after surgery)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of Zurich; University Hospital, Geneva
• Investigators: Study Chair: Gabor Erdoes, MD, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BASEC 2023-D0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No