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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Hemorrhage, Surgical
• Intervention / Treatment: Device: Cell Salvage Autotransfusion: SAME™ device; Device: Cell Salvage Autotransfusion: Autolog™ device

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Schiffer, MD; Phone Number: +41 22 372 3060; Email: eduardo.schiffer@hcuge.ch
• Study Contact Backup: Name: Tony Mouawad, MD; Phone Number: +41 79 553 2117; Email: tony.mouawad@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Geneva University Hospitals
    • Contact: Eduardo Schiffer, MD; Email: eduardo.schiffer@hcuge.ch
    • Principal Investigator: Tony Mouawad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAME™ Device group; SAME™ Autotransfusion Device that is being tested for recovery of platelets along with RBCs	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.
Active Comparator: Autolog™ Device group; Autolog™ standard autotransfusion device currently used at our institution	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet number	Platelet number will be measured using flow cytometry in the laboratory after processing and after retransfusion of the salvaged blood to the patient.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet function	Platelets function will be assessed by multiple electrode aggregometry (Multiplate® analyzer, Roche Diagnostics, Mannheim, Germany).	Day 1
Platelet function	Platelets function will be measured by platelet activation markers (P-selectin)	Day 1
Platelet function	Platelets function will be measured by platelet activation markers (GPIb)	Day 1
Platelet function	Platelets function will be measured by platelet activation markers (GPIIb)	Day 1
Platelet function	Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using ExTest.	Day 1
Platelet function	Platelets function will be measured by point-of-care test (ClotPro, Hemonetics Corporation, Boston, MA, USA) using FibTest assays.	Day 1
Blood plasma albumin level	measured by spectrophotometry	Day 1
Blood hemoglobin level	measured by spectrophotometry	Day 1
Blood lactate level	measured by spectrophotometry	Day 1
Free hemoglobin level	measured by spectrophotometry	Day 1
Anti-Xa activity	measured by Anti-Xa assay	Day 1
Number of allogeneic blood products used	Number of allogeneic blood products used (red blood cell, fresh frozen plasma, platelet concentrates) until ICU discharge	Day 1
Number of coagulation concentrates used	Number of coagulation concentrates used (prothrombin complex concentrate, fibrinogen concentrate) until ICU discharge	Day 1
Amount of autologous blood at the end of the liver transplantation	Amount of autologous blood at the end of the liver transplantation	Day 1

Collaborators and Investigators

• Sponsor: Eduardo Schiffer
• Collaborators: University Hospital, Geneva; Insel Gruppe AG, University Hospital Bern
• Investigators: Study Director: Eduardo Schiffer, MD, University Hospital, Geneva

Publications and helpful links

General Publications

• Klein AA, Bailey CR, Charlton AJ, Evans E, Guckian-Fisher M, McCrossan R, Nimmo AF, Payne S, Shreeve K, Smith J, Torella F. Association of Anaesthetists guidelines: cell salvage for peri-operative blood conservation 2018. Anaesthesia. 2018 Sep;73(9):1141-1150. doi: 10.1111/anae.14331. Epub 2018 Jul 10.
• Mansour A, Beurton A, Godier A, Rozec B, Zlotnik D, Nedelec F, Gaussem P, Fiore M, Boissier E, Nesseler N, Ouattara A. Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study). Anesthesiology. 2023 Sep 1;139(3):287-297. doi: 10.1097/ALN.0000000000004642.
• Mansour A, Decouture B, Roussel M, Lefevre C, Skreko L, Picard V, Ouattara A, Bachelot-Loza C, Gaussem P, Nesseler N, Gouin-Thibault I. Combined Platelet and Erythrocyte Salvage: Evaluation of a New Filtration-based Autotransfusion Device. Anesthesiology. 2021 Aug 1;135(2):246-257. doi: 10.1097/ALN.0000000000003820.
• Sikorski RA, Rizkalla NA, Yang WW, Frank SM. Autologous blood salvage in the era of patient blood management. Vox Sang. 2017 Aug;112(6):499-510. doi: 10.1111/vox.12527. Epub 2017 Jun 5.
• Schreiber K, Decouture B, Lafragette A, Chollet S, Bruneau M, Nicollet M, Wittmann C, Gadrat F, Mansour A, Forest-Villegas P, Gauthier O, Touzot-Jourde G. A novel autotransfusion device saving erythrocytes and platelets used in a 72 h survival swine model of surgically induced controlled blood loss. PLoS One. 2022 Mar 24;17(3):e0260855. doi: 10.1371/journal.pone.0260855. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: Platelet CellSaver Liver trnsp

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No