Blood Salvage in Orthotopic Liver Transplantation With HCC

Hepatocellular Carcinoma Clinical Trial

— SOLT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05612477
• Other study ID #: 20-5903
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 21, 2023
• Est. completion date: December 31, 2034

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Surgery

Intervention

Procedure:
• Autotransfusion
blood is collected from the surgical field, washed, processed and transfused back into the patient

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility- enrollment	to determine whether we can meet enrollment goals within the study period	15 months
Secondary	Safety- HCC recurrence	compare rates of HCC recurrence between groups	1 year post-transplant