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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
| University of Zurich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing cardiac surgery using the conventional cell saver device | Active Comparator |
| |
| Patients undergoing cardiac surgery using the cell saver device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Platelet function measured by platelet activation markers (P-selectin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Barattiero, MD | Contact | 004131632111 | fabio.barattiero@insel.ch | |
| Gabor Erdoes, MD | Contact | 004131632111 | gabor.erdoes@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Gabor Erdoes, MD | University of Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine | Recruiting | Bern | 3010 | Switzerland |
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| 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. |
|
Platelet function, as measured by point-of-care test |
| 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) | Platelet function, as measured by point-of-care test | 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) | 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) |
| 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) |
| 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) |