Clinical trial NCT06405516: Platelet Function After Cardiac Surgery.
Official title: Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Platelet Dysfunction
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: University of Zurich
First posted: 2024-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Platelet number
timeFrame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Secondary outcomes:
measure: Platelet function measured by multiple electrode aggregometry
timeFrame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
measure: Platelet function measured by platelet activation markers (P-selectin)
timeFrame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
measure: Platelet function measured by platelet activation markers (GPIb and GPIIb)
timeFrame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
measure: Platelet function measured with viscoelastic point-of-care test (Clotpro)
timeFrame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
measure: Platelet function measured with viscoelastic point-of-care test (ROTEM)
timeFrame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
measure: Number of allogeneic blood products transfused
timeFrame: Perioperative period (begins on the day of surgery and ends on the day after surgery)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anesthesiology and Pain Medicine
Study officials:
affiliation: University of Bern
name: Gabor Erdoes, MD
role: STUDY_CHAIR
References: