Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery

Not Applicable

Not yet recruiting

• Conditions: Liver Transplant; Hemorrhage, Surgical

• Registration Number: NCT06357455
• Lead Sponsor: Eduardo Schiffer

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).

Study Timeline

• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Platelet number	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 Outcome Measures

Name	Time	Method
Blood lactate level	Day 1	measured by spectrophotometry
Blood plasma albumin level	Day 1	measured by spectrophotometry
Blood hemoglobin level	Day 1	measured by spectrophotometry
Platelet function	Day 1	Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using FibTest assays.
Free hemoglobin level	Day 1	measured by spectrophotometry
Number of allogeneic blood products used	Day 1	Number of allogeneic blood products used (red blood cell, fresh frozen plasma, platelet concentrates) until ICU discharge
Anti-Xa activity	Day 1	measured by Anti-Xa assay
Amount of autologous blood at the end of the liver transplantation	Day 1	Amount of autologous blood at the end of the liver transplantation
Number of coagulation concentrates used	Day 1	Number of coagulation concentrates used (prothrombin complex concentrate, fibrinogen concentrate) until ICU discharge

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland