Autotransfusion During Liver Transplant for Liver Cancer

(SOLT Trial)

Overseen By Gonzalo Sapisochin, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Other malignancies, Pediatric, Re-transplantation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration

30 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment IBSA during liver transplant for liver cancer?

Research shows that using IBSA during liver transplants for liver cancer does not increase the risk of cancer coming back. Studies found similar recurrence rates in patients who had IBSA and those who did not, suggesting it is a safe option. ^{1 2 3 4 5}

Is autotransfusion during liver transplant for liver cancer safe?

The research articles provided do not contain specific safety data on autotransfusion during liver transplant for liver cancer. They focus on the safety of hepatitis B immunoglobulin in liver transplant patients, which is generally considered safe, but this is not directly related to autotransfusion. ^{6 7 8 9 10}

How does the treatment of autotransfusion during liver transplant for liver cancer differ from other treatments?

Autotransfusion during liver transplant for liver cancer is unique because it involves collecting and reinfusing the patient's own blood during surgery, which can reduce the need for donor blood. This approach is controversial due to concerns about reinfusing blood that might contain cancer cells, but studies suggest it does not increase the risk of cancer recurrence. ^{1 2 3 4 5}

Research Team

Gonzalo Sapisochin, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults with Hepatocellular carcinoma (HCC) who are listed for a liver transplant. It excludes those with other cancers like mixed cholangiocarcinoma-HCC, cholangiocarcinoma, metastatic colorectal cancer, children under 18, and patients undergoing re-transplantation or multi-organ transplantation.

Inclusion Criteria

I have been diagnosed with liver cancer.

I am on the waiting list for a liver transplant.

Exclusion Criteria

I am scheduled for or have had a second organ transplant.

I have had multiple organ transplants.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo liver transplantation surgery with intraoperative blood cell salvage and autotransfusion (IBSA) or no autotransfusion

Surgery duration

1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy outcomes related to overall transfusion requirements and cancer recurrence

24 months

Regular follow-up visits

Long-term follow-up

Participants are monitored for HCC recurrence and survival rates

1 year post-transplant

Treatment Details

Interventions

• IBSA

Trial Overview The study tests the use of intraoperative blood cell salvage and autotransfusion (IBSA), where a patient's own blood collected during surgery is cleaned and returned to them. The trial will compare outcomes between patients receiving their own salvaged blood versus those whose collected blood is discarded.

Participant Groups

Group I: Autotransfusion Experimental Treatment 1 Intervention

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

Group II: No Autotransfusion Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical prognosis of intraoperative blood salvage autotransfusion in liver transplantation for hepatocellular carcinoma: A systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Blood Cell Salvage and Autotransfusion Does Not Worsen Oncologic Outcomes Following Liver Transplantation with Incidental Hepatocellular Carcinoma: A Propensity Score-Matched Analysis. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Liver transplantation for hepatocellular carcinoma--is there a risk of recurrence caused by intraoperative blood salvage autotransfusion? [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Controversy over the use of intraoperative blood salvage autotransfusion during liver transplantation for hepatocellular carcinoma patients. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Blood salvage autotransfusion during transplantation for hepatocarcinoma: does it increase the risk of neoplastic recurrence? [2005]

6. China pubmed.ncbi.nlm.nih.gov

[The study of the different medicating ways and the formula for intravenous loading dosage of hepatitis B immunoglobulin in liver transplantation]. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

A Multicenter Phase III Study to Evaluate the Efficacy and Safety of Hepabulin, a New Hepatitis B Immunoglobulin, in Liver Transplantation Recipients with Hepatitis B. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness, Safety, and Patient-Reported Outcomes of Self-Administered Subcutaneous Hepatitis B Immunoglobulin in Liver Post-Transplant Hepatitis B Prophylaxis: A Prospective Non-Interventional Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Hepatitis B reactivation in HBsAg-negative/HBcAb-positive allogeneic haematopoietic stem cell transplant recipients: risk factors and outcome. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of ultra-rapid intravenous infusion of hepatitis B immunoglobulin in liver transplant recipients. [2022]