Blood Salvage in Orthotopic Liver Transplantation with HCC (SOLT)

March 13, 2025 updated by: University Health Network, Toronto

Blood Salvage in Orthotopic Liver Transplantation with HCC: a Randomized Open-labelled Trial of Effectiveness & Safety (SOLT Trial) - a Pilot Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Blood loss during liver transplantation (LT) often necessitates transfusion. However, allogeneic blood transfusion (blood from a donor) has risks. For this reason, intraoperative blood cell salvage and autotransfusion (IBSA) is frequently deployed to reduce the need for allogeneic blood transfusion. While IBSA is often used in LT, it is rarely used in patients undergoing LT for hepatocellular carcinoma (HCC) due to the theoretical risk of re-infusing cancer cells.

This single-centre, randomized, pilot study, will investigate the feasibility, safety, and efficacy of IBSA in patients undergoing LT for HCC.

Patients with HCC, listed for a Liver Transplant at the study institution, will be consented in clinic. At the time of liver transplant surgery, patients will be randomized, provided that enough blood is collected to generate a minimum of 1 unit of washed RBCs to give back. Participants randomized to arm 1 will receive their autologous blood via transfusion. Participants randomized to arm 2 will not receive their autologous blood - instead the blood will be discarded. Following surgery, participants will be followed for evaluation of safety and efficacy outcomes related to overall transfusions requirements and cancer recurrence.

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 (producing a minimum of 1 unit of washed RBCs).

Secondary outcomes include: whether the study can meet its accrual and enrollment goals within the study period; a comparison of rates of patient survival and HCC recurrence between the study groups; a comparison of the patient characteristics of those randomized to those not randomized. Blood will also be collected for correlative studies.

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Listed for a liver transplant
  • diagnosis of Hepatocellular carcinoma

Exclusion Criteria:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autotransfusion
patients in this arm will receive their salvaged and washed RBCs via transfusion
Procedure: Autotransfusion
blood is collected from the surgical field, washed, processed and transfused back into the patient
No Intervention: No Autotransfusion
patients in this arm will have their salvaged and washed RBCs discarded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility -Accrual
Time Frame: through study completion, an average of 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility- enrollment
Time Frame: 15 months
to determine whether we can meet enrollment goals within the study period
15 months
Safety- HCC recurrence
Time Frame: 1 year post-transplant
compare rates of HCC recurrence between groups
1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Gonzalo Sapisochin, MD, PhD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2023

Primary Completion (Actual)

January 31, 2025

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-5903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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