Platelet Function After Cardiac Surgery.

Platelet Dysfunction Clinical Trial

— PLFICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405516
• Other study ID #: BASEC 2023-D0074
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Fabio Barattiero, MD
• Phone: 004131632111
• Email: fabio.barattiero[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Platelet Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Anesthesiology and Pain Medicine	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	University Hospital, Geneva, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)