Platelet Function After Cardiac Surgery.
ConditionPlatelet Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Elective high risk cardiac surgery with cardiopulmonary bypass usage
Cardiopulmonary bypass time > 120 minutes
Written informed consent
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous blood cell salvage with in-house device
DeviceIn 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
DeviceIn 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Patients undergoing cardiac surgery using the conventional cell saver deviceActive comparator 1 intervention
Group B: Patients undergoing cardiac surgery using the cell saver deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Platelet number
Platelet number as measured by flow cytometry after processing and retransfusion of the salvaged blood to the patient.
Time frame
Perioperative period (begins on the day of surgery and ends on the day after surgery)Secondary outcomes
1
Platelet function measured by multiple electrode aggregometry
Platelet function, as measured by point-of-care test
Time frame
Perioperative period (begins on the day of surgery and ends on the day after surgery)2
Platelet function measured by platelet activation markers (P-selectin)
Platelet function, as measured by point-of-care test
Time frame
Perioperative period (begins on the day of surgery and ends on the day after surgery)3
Platelet function measured by platelet activation markers (GPIb and GPIIb)
Platelet function, as measured by point-of-care test
Time frame
Perioperative period (begins on the day of surgery and ends on the day after surgery)4
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
Time frame
Perioperative period (begins on the day of surgery and ends on the day after surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
University Hospital, Geneva
Collaborator
University of Zurich
Collaborator
Source ClinicalTrials.gov