NCT06357455

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

Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery: A Randomized Controlled Bi-Center Equivalence Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Eduardo Schiffer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Liver Transplant
• Hemorrhage, Surgical

Interventions

Type	Name	Description
DEVICE	Cell Salvage Autotransfusion: SAME™ 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.
DEVICE	Cell Salvage Autotransfusion: Autolog™ device	* 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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: Switzerland