Blood Salvage in Orthotopic Liver Transplantation With HCC

NCT05612477 | Active Not Recruiting

• 1 other identifier: 20-5903
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Surgery

Keywords

Liver transplantation

Outcome Measures

Primary Outcomes (1)

• Feasibility -Accrual

  The primary outcome is an evaluation of how many patients who consent to the trial will experience enough blood loss during surgery to be randomizable according to the study design. This will be measured by comparing the number of consented patients undergoing LT who meet randomization requirements compared to those who do not.

  through study completion, an average of 24 months

Secondary Outcomes (2)

• Feasibility- enrollment

  15 months

• Safety- HCC recurrence

  1 year post-transplant

Study Arms (2)

Autotransfusion

EXPERIMENTAL

patients in this arm will receive their salvaged and washed RBCs via transfusion

Procedure: Autotransfusion

No Autotransfusion

NO INTERVENTION

patients in this arm will have their salvaged and washed RBCs discarded.

Interventions

Autotransfusion PROCEDURE

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

Autotransfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Listed for a liver transplant
• diagnosis of Hepatocellular carcinoma

You may not qualify if:

• \- Patients with malignancy other than HCC, such as mixed cholangiocarcinoma-hepatocellular carcinoma, cholangiocarcinoma, and metastatic colorectal cancer. Patients who had a preoperative diagnosis of HCC but a postoperative diagnosis of any of the above will be analyzed separately.
• Pediatric patients (age\<18 years at the time of screening)
• Patients undergoing re-transplantation
• Multi-organ transplantation

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Blood Transfusion, Autologous

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Gonzalo Sapisochin, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: January 21, 2023
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2034
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

CA (1)