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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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\- 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

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Liver Transplant Hemorrhage, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAME™ Device group

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

Group Type EXPERIMENTAL

Cell Salvage Autotransfusion: SAME™ device

Intervention Type 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.

Autolog™ Device group

Autolog™ standard autotransfusion device currently used at our institution

Group Type ACTIVE_COMPARATOR

Cell Salvage Autotransfusion: Autolog™ device

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes