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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach called IBSA during liver transplant surgery for liver cancer. IBSA involves collecting a patient’s own blood during surgery, cleaning it, and then returning it to them. Participants will either receive this blood transfusion or not, to determine its safety and effectiveness. Those diagnosed with liver cancer (hepatocellular carcinoma) and listed for a liver transplant might be suitable candidates. The trial's results could lead to a larger study to better understand how this method affects the need for donor blood and recovery outcomes. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could improve future liver transplant procedures.

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 prior data suggests that this method is safe for liver transplant patients?

Research has shown that intraoperative blood cell salvage and autotransfusion (IBSA) during liver cancer transplants is generally safe. Studies have found that IBSA does not increase cancer recurrence or affect survival rates compared to regular blood transfusions. Patients receiving their own blood during surgery experience similar outcomes to those receiving donor blood. Additionally, IBSA reduces the need for donor blood, which is beneficial. Overall, current evidence supports that IBSA is well-tolerated and does not introduce extra risks during liver cancer transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about autotransfusion during liver transplants for liver cancer because it offers a unique way to reduce the need for donor blood. Unlike traditional methods that rely on external blood transfusions, autotransfusion uses the patient's own salvaged and washed red blood cells, potentially lowering the risk of transfusion reactions and infections. This approach not only enhances safety but could also improve recovery times by ensuring the body receives compatible blood. By exploring this technique, researchers hope to find a more efficient and safer alternative to standard blood transfusions during liver transplantation.

What evidence suggests that IBSA is effective for liver transplantation in liver cancer?

This trial will compare intraoperative blood cell salvage and autotransfusion (IBSA) with no autotransfusion during liver transplants for liver cancer, specifically hepatocellular carcinoma (HCC). Research has shown that IBSA is beneficial and does not increase the risk of cancer recurrence. Studies indicate that IBSA offers survival rates similar to regular blood transfusions and does not lead to higher cancer recurrence after the transplant. This method reduces the need for donated blood during surgery, which can be advantageous. Additionally, IBSA has not been linked to worse cancer outcomes, making it a promising approach to managing blood loss during liver transplants. ^{2 3 4 6 7}

Who Is on the Research Team?

Gonzalo Sapisochin, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9622948/

Clinical prognosis of intraoperative blood salvage ...

IBSA provides comparable survival outcomes relative to allogeneic blood transfusion and does not increase the tumor recurrence for HCC patients after LT.

2.

journals.lww.com

journals.lww.com/annalsofsurgery/fulltext/2022/08000/safety_of_intraoperative_blood_salvage_during.7.aspx

Intraoperative Blood Salvage in Liver Transplant for HCC

The effects of intraoperative blood salvage (IBS) on time to tumor recurrence, disease-free survival and overall survival in hepatocellular carcinoma (HCC) ...

3.

academic.oup.com

academic.oup.com/bjsopen/article/9/5/zraf101/8250165

Effect of intraoperative autotransfusion use during liver ...

The use of autotransfusion during liver transplantation for hepatocellular carcinoma was not associated with recurrence-free survival. Topic:.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1365182X21006158

Intraoperative autologous transfusion and oncologic ...

IAT during LT for HCC is not associated with adverse oncologic outcomes. Use of IAT should be encouraged to minimize the volume of allogenic transfusion.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06307158

NCT06307158 | Influence of Intraoperative Blood Salvage ...

Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9259047/

Safety of Intraoperative Blood Salvage During Liver ...

Use of IBS during liver transplantation in patients with HCC does not result in impaired disease-free survival, increased HCC recurrence or impaired overall ...

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05612477/blood-salvage-in-orthotopic-liver-transplantation-with-hcc?activelyRecruiting=false&page=461&id=1022&slug=cancer

Blood Salvage in Orthotopic Liver Transplantation with HCC

This single-centre randomized pilot study will investigate the feasibility, safety, and efficacy of IBSA (intraoperative blood cell salvage ...