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.