An interventional study of Cell Salvage Autotransfusion: SAME™ device and Cell Salvage Autotransfusion: Autolog™ device in Liver Transplant and Hemorrhage, Surgical, sponsored by Eduardo Schiffer. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Eduardo Schiffer · Not applicable, Interventional, and Treatment
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →This is the only study on the registry with Eduardo Schiffer as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SAME™ Autotransfusion Device that is being tested for recovery of platelets along with RBCs
Device: Cell Salvage Autotransfusion: SAME™ device
Autolog™ standard autotransfusion device currently used at our institution
Device: Cell Salvage Autotransfusion: Autolog™ device
* 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.
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
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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