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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06357455
Other study ID # Platelet CellSaver Liver trnsp
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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