Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-06-12
2026-01-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Patients undergoing cardiac surgery using the conventional cell saver 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.
Patients undergoing cardiac surgery using the cell saver device
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Elective high risk cardiac surgery with cardiopulmonary bypass usage
* Cardiopulmonary bypass time \> 120 minutes
* Written informed consent
Exclusion Criteria
* Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
University of Zurich
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Gabor Erdoes, MD
Role: STUDY_CHAIR
University of Bern
Locations
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Department of Anesthesiology and Pain Medicine
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BASEC 2023-D0074
Identifier Type: -
Identifier Source: org_study_id
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