Platelet Function After Cardiac Surgery.
- Conditions
- Platelet Dysfunction
- Interventions
- Device: Autologous blood cell salvage with in-house deviceDevice: Autologous cell salvage with i-Sep SAME device
- Registration Number
- NCT06405516
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Age >18 years
- Elective high risk cardiac surgery with cardiopulmonary bypass usage
- Cardiopulmonary bypass time > 120 minutes
- Written informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients undergoing cardiac surgery using the conventional cell saver device Autologous blood cell salvage with in-house device - Patients undergoing cardiac surgery using the cell saver device Autologous cell salvage with i-Sep SAME device -
- Primary Outcome Measures
Name Time Method Platelet number 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 Outcome Measures
Name Time Method Platelet function measured by multiple electrode aggregometry Perioperative period (begins on the day of surgery and ends on the day after surgery) Platelet function, as measured by point-of-care test
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, as measured by point-of-care test
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, as measured by point-of-care test
Number of allogeneic blood products transfused 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)
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 by point-of-care test using ExTest und FibTest assays with viscoelastic point-of-care test device
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) Platelet function, measured by point-of-care test using ExTEM und FibTEM assays with viscoelastic point-of-care test device
Trial Locations
- Locations (1)
Department of Anesthesiology and Pain Medicine
🇨🇭Bern, Switzerland