NCT05612477Active, not recruiting
Blood Salvage in Orthotopic Liver Transplantation With HCC
Blood Salvage in Orthotopic Liver Transplantation With HCC: A Randomized Open-labelled Trial of Effectiveness & Safety (SOLT Trial) - A Pilot Trial
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Nov 2022
- Start date
- 21 Jan 2023
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05612477
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 21 Jan 2023 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing re-transplantation
- Multi-organ transplantation
Other illness
- \- 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.
Age
- Pediatric patients (age\<18 years at the time of screening)
Who the study is looking for
- Listed for a liver transplant
- diagnosis of Hepatocellular carcinoma
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.