Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk 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 status after these types of surgeries, especially liver transplantation. 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 re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population. The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.
\- Study design: Randomized controlled bi-center trial * Primary objective: to compare platelet number and function after processing and re-transfusion of the salvaged blood to the patient by using different cell saver devices. * Secondary (main) objectives: to compare a) the coagulation profile and b) the usage of blood products (frequency of administration of labile and stable blood products).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
* Intervention studied: processing of salvaged blood using the SAME™ autotransfusion device * Population studied: 20 patients planned to undergo high-risk liver transplantation. * "Treatment" group. All perioperative measures will be performed according to international, national and in-house standards.
* Intervention studied: processing of salvaged blood using the Autolog™ (Medtronic) autotransfusion device (in-house standard device). * Population studied: 20 patients planned to undergo high-risk liver transplantation. * "Control" group All perioperative measures will be performed according to international, national and in-house standards.
Geneva University Hospitals
Geneva, Switzerland
Platelet number
Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient.
Time frame: Day 1
Platelet function
Platelets function will be assessed by multiple electrode aggregometry (Multiplate® analyzer, Roche Diagnostics, Mannheim, Germany).
Time frame: Day 1
Platelet function
Platelets function will be measured by platelet activation markers (P-selectin)
Time frame: Day 1
Platelet function
Platelets function will be measured by platelet activation markers (GPIb)
Time frame: Day 1
Platelet function
Platelets function will be measured by platelet activation markers (GPIIb)
Time frame: Day 1
Platelet function
Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using ExTest.
Time frame: Day 1
Platelet function
Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using FibTest assays.
Time frame: Day 1
Blood plasma albumin level
measured by spectrophotometry
Time frame: Day 1
Blood hemoglobin level
measured by spectrophotometry
Time frame: Day 1
Blood lactate level
measured by spectrophotometry
Time frame: Day 1
Free hemoglobin level
measured by spectrophotometry
Time frame: Day 1
Anti-Xa activity
measured by Anti-Xa assay
Time frame: Day 1
Number of allogeneic blood products used
Number of allogeneic blood products used (red blood cell, fresh frozen plasma, platelet concentrates) until ICU discharge
Time frame: Day 1
Number of coagulation concentrates used
Number of coagulation concentrates used (prothrombin complex concentrate, fibrinogen concentrate) until ICU discharge
Time frame: Day 1
Amount of autologous blood at the end of the liver transplantation
Amount of autologous blood at the end of the liver transplantation
Time frame: Day 1
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