Platelet Dysfunction
Conditions
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.
Interventions
DEVICEAutologous 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.
DEVICEAutologous 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.
Sponsors
University Hospital, Geneva
University of Zurich
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 |
| 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 |
Countries
Switzerland
Contacts
Primary ContactFabio Barattiero, MD
Backup ContactGabor Erdoes, MD
Outcome results
None listed