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

Eduardo Schiffer

Status: Not yet enrolling

Conditions: Hemorrhage, Surgical; Liver Transplant

Treatments: Device: Cell Salvage Autotransfusion: Autolog™ device; Device: Cell Salvage Autotransfusion: SAME™ device

Study type: Interventional

Funder types: Other

Identifiers

NCT06357455

Platelet CellSaver Liver trnsp

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

SAME™ Device group

Experimental group

Description:

SAME™ Autotransfusion Device that is being tested for recovery of platelets along with RBCs

Treatment:

Device: Cell Salvage Autotransfusion: SAME™ device

Autolog™ Device group

Active Comparator group

Description:

Autolog™ standard autotransfusion device currently used at our institution

Treatment:

Device: Cell Salvage Autotransfusion: Autolog™ device