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

NCT06357455 | Not Yet Recruiting

• 1 other identifier: Platelet CellSaver Liver trnsp
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplant; Hemorrhage, Surgical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Platelet function

  Day 1

• Platelet function

  Day 1

• Platelet function

  Day 1

• Platelet function

  Day 1

• Platelet function

  Day 1

Study Arms (2)

SAME™ Device group

EXPERIMENTAL

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

Device: Cell Salvage Autotransfusion: SAME™ device

Autolog™ Device group

ACTIVE COMPARATOR

Autolog™ standard autotransfusion device currently used at our institution

Device: Cell Salvage Autotransfusion: Autolog™ device

Interventions

Cell Salvage Autotransfusion: SAME™ device 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.

SAME™ Device group

Cell Salvage Autotransfusion: Autolog™ device 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.

Autolog™ Device group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients undergoing liver transplantation surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Eduardo Schiffer: lead
• University Hospital, Geneva: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 37294939 BACKGROUND

• 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.

  PMID: 33984126 BACKGROUND

• 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.

  PMID: 29989144 BACKGROUND

• 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.

  PMID: 28580663 BACKGROUND

• 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.

  PMID: 35324911 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Eduardo Schiffer, MD

  University Hospital, Geneva

  STUDY DIRECTOR

Central Study Contacts

Eduardo Schiffer, MD

CONTACT

+41 22 372 3060; eduardo.schiffer@hcuge.ch

Tony Mouawad, MD

CONTACT

+41 79 553 2117; tony.mouawad@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Head of Unit

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 10, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CH (1)