NCT05612477.
Study name | SOLT |
Methods | Single‐centre randomised pilot study of adults aged over 18 years undergoing liver transplantation for hepatocellular carcinoma (HCC). The method of randomisation and allocation concealment is not described. The study is described as double‐blind (investigator and outcome assessor). |
Participants | Adults aged over 18 years undergoing liver transplantation for hepatocellular carcinoma (HCC) will be randomly allocated to one of two groups. The estimated enrolment number is 30 participants. Experimental arm (Autotransfusion group) No intervention arm (Control group) Inclusion criteria
Exclusion criteria
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Interventions |
Experimental arm (Autotransfusion group): participants in the experimental group will have blood collected from the surgical field, washed, processed and re‐transfused No intervention arm (Control group): participants in the control group will have their salvaged and washed red blood cells discarded |
Outcomes | Feasability ‐ accrual (how many participants who consent to the trial will experience enough blood loss during surgery to be randomisable according to the study design); feasability ‐ enrolment (whether it is possible to meet enrolment goals within the study period); safety ‐ HCC recurrence |
Starting date | 07 November 2022 |
Contact information | Contact: Erin Winter, BSc 416‐340‐4800 ext 6093 erin.winter@uhn.ca Contact: Gonzalo Sapisochin, MD, PhD 416‐340‐4800 |
Notes |
Transfusion protocol: use of a transfusion protocol is not reported Prospective registration status: study was registered prospectively on ClinicalTrials.gov (date of registration 10 November 2022) Ethical approval: not known whether the study has been approved by an ethics committee or institutional review board Language: information available on ClinicalTrials.gov is in English Status: Last update posted: 10 November 2022 Not yet recruiting |
Hb: haemoglobin