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ACTIVE NOT RECRUITING
NCT05612477
NA

Blood Salvage in Orthotopic Liver Transplantation With HCC

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

This single-centre randomized pilot study will investigate the feasibility, safety, and efficacy of IBSA (intraoperative blood cell salvage and autotransfusion -when a patient's own blood is collected from the surgical field, washed, and transfused back to them), in patients undergoing Liver transplantation for Hepatocellular carcinoma (HCC). A total of 30 patient participants will be enrolled. A participant will be randomized only if enough blood is collected during the transplant surgery to produce a minimum of 1 unit of autologous blood. Patients will be randomized to receive their blood back (via transfusion) or have their own blood discarded. Patients will be followed after surgery for evaluation of safety and efficacy. Depending on the outcomes of this feasibility trial, a subsequent larger full-scale multi-institutional trial will be planned, which will be more appropriately powered to evaluate the true impact of IBSA on the use of allogeneic blood products and post-transplant HCC-specific outcomes.

Official title: Blood Salvage in Orthotopic Liver Transplantation With HCC: A Randomized Open-labelled Trial of Effectiveness & Safety (SOLT Trial) - A Pilot Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-01-21

Completion Date

2034-12-31

Last Updated

2025-03-17

Healthy Volunteers

No

Interventions

PROCEDURE

Autotransfusion

blood is collected from the surgical field, washed, processed and transfused back into the patient

Locations (1)

University Health Network

Toronto, Ontario, Canada