Platelet Function After Cardiac Surgery.

NCT06405516 | Recruiting

• 1 other identifier: BASEC 2023-D0074
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Platelet function measured by multiple electrode aggregometry

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

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

  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)

  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)

  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)

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

Study Arms (2)

Patients undergoing cardiac surgery using the conventional cell saver device

ACTIVE COMPARATOR

Device: Autologous blood cell salvage with in-house device

Patients undergoing cardiac surgery using the cell saver device

EXPERIMENTAL

Device: Autologous cell salvage with i-Sep SAME device

Interventions

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.

Patients undergoing cardiac surgery using the conventional cell saver device

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.

Patients undergoing cardiac surgery using the cell saver device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Elective high risk cardiac surgery with cardiopulmonary bypass usage
• Cardiopulmonary bypass time \> 120 minutes
• Written informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Geneva: collaborator
• University of Zurich: collaborator

Study Sites (1)

Department of Anesthesiology and Pain Medicine

Bern, 3010, Switzerland

RECRUITING

Study Officials

• Gabor Erdoes, MD

  University of Bern

  STUDY CHAIR

Central Study Contacts

Fabio Barattiero, MD

CONTACT

004131632111; fabio.barattiero@insel.ch

Gabor Erdoes, MD

CONTACT

004131632111; gabor.erdoes@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 8, 2024
• Study Start: June 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)