Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery: A Randomized Controlled Bi-Center Equivalence Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Transplant
- Sponsor
- Eduardo Schiffer
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Platelet number
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
- 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).
Investigators
Eduardo Schiffer
Professor, Head of Unit
University Hospital, Geneva
Eligibility Criteria
Inclusion Criteria
- •All adult patients undergoing liver transplantation surgery
Exclusion Criteria
- •Age \< 18 years old
- •Active liver malignancy
- •Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
- •Inability to understand and sign the informed consent form
Outcomes
Primary Outcomes
Platelet number
Time Frame: Day 1
Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient.
Secondary Outcomes
- Blood lactate level(Day 1)
- Blood plasma albumin level(Day 1)
- Blood hemoglobin level(Day 1)
- Platelet function(Day 1)
- Free hemoglobin level(Day 1)
- Number of allogeneic blood products used(Day 1)
- Anti-Xa activity(Day 1)
- Amount of autologous blood at the end of the liver transplantation(Day 1)
- Number of coagulation concentrates used(Day 1)