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NCT05612477
Blood Salvage in Orthotopic Liver Transplantation With HCC
Conditions: Hepatocellular Carcinoma, Surgery
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: University Health Network, Toronto
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.
Eligibility Criteria
Inclusion Criteria:Listed for a liver transplantdiagnosis of Hepatocellular carcinomaExclusion 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-transplantationMulti-organ transplantation
Source: ClinicalTrials.gov (NCT05612477). StuddyBuddy aggregates publicly available trial information.