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

Liver Transplant Clinical Trial

— PLFLTS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357455
• Other study ID #: Platelet CellSaver Liver trnsp
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Geneva
• Contact: Eduardo Schiffer, MD
• Phone: +41 22 372 3060
• Email: eduardo.schiffer[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Hemorrhage, Surgical
• Liver Transplant

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Eduardo Schiffer	Insel Gruppe AG, University Hospital Bern, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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