Platelet Function After Cardiac Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous blood cell salvage with in-house device, Autologous cell salvage with i-Sep SAME device.
- Who it may be relevant to
- Registry conditions: Platelet Dysfunction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.
Overview
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
- 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. - 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.
Primary outcome measures
- Platelet number [Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
Secondary outcome measures (6)
- Platelet function measured by multiple electrode aggregometry [Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
- Platelet function measured by platelet activation markers (P-selectin) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
- Number of allogeneic blood products transfused [Time frame: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Switzerland · 1 center
- Department of Anesthesiology and Pain Medicine — Bern
Identifiers
NCT: NCT06405516 · BASEC 2023-D0074