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. 2023 Sep 8;2023(9):CD001888. doi: 10.1002/14651858.CD001888.pub5

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
  • 18 years or older

  • Listed for a liver transplant

  • Diagnosis of hepatocellular carcinoma


Exclusion criteria
  • 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 analysed separately.

  • Pediatric participants (age <18 years at the time of screening)

  • Participants undergoing re‐transplantation

  • Multi‐organ transplantation

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