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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Preliminary results of a clinical randomized study comparing Celsior and HTK solutions in liver preservation for transplantation.
Transplantation Proceedings 2005 January
INTRODUCTION: A prospective, randomized, multicenter, open clinical trial was performed to compare the main liver function tests, postoperative complications, and early graft and patient survival of recipients transplanted with livers preserved in Celsior (CEL) versus histidine tryptophan ketoglutarate (HTK) solutions.
METHODS: We analyzed the data from a single center. Forty livers randomized to CEL (n = 20) or HTK (n = 20) preservation solution were perfused in situ via the aorta and portal vein (CEL, 30 mL/kg via portal vein and 60 mL/kg via aorta; and HTK solution, 30 mL/kg via portal vein and 120 mL/kg via aorta).
RESULTS: The groups were comparable with regard to donor, graft, and recipient characteristics. The mean cold ischemia time was 458 minutes (range: 203-667 minutes) in CEL and 450 (range: 310-684 minutes) in HTK. The incidence of initial poor function and primary nonfunction in CEL and HTK were (0 vs 1) and (0 vs 1), respectively. No differences were observed for acute rejection. No vascular or biliary complications were reported in either group. The 3-month graft and patient survival rates were 95% and 95% in CEL and 80% and 90% in HTK. The 12-month graft and patient survival rates were 90% and 90% in CEL and 75% and 85% in HTK.
CONCLUSIONS: To our knowledge, this is the first report comparing CEL and HTK preservation solutions in clinical liver preservation. Although a greater 1-year graft and patient survival was observed in the CEL group, a definitive evaluation comparing CEL and HTK solutions in clinical preservation must await completion of the trial.
METHODS: We analyzed the data from a single center. Forty livers randomized to CEL (n = 20) or HTK (n = 20) preservation solution were perfused in situ via the aorta and portal vein (CEL, 30 mL/kg via portal vein and 60 mL/kg via aorta; and HTK solution, 30 mL/kg via portal vein and 120 mL/kg via aorta).
RESULTS: The groups were comparable with regard to donor, graft, and recipient characteristics. The mean cold ischemia time was 458 minutes (range: 203-667 minutes) in CEL and 450 (range: 310-684 minutes) in HTK. The incidence of initial poor function and primary nonfunction in CEL and HTK were (0 vs 1) and (0 vs 1), respectively. No differences were observed for acute rejection. No vascular or biliary complications were reported in either group. The 3-month graft and patient survival rates were 95% and 95% in CEL and 80% and 90% in HTK. The 12-month graft and patient survival rates were 90% and 90% in CEL and 75% and 85% in HTK.
CONCLUSIONS: To our knowledge, this is the first report comparing CEL and HTK preservation solutions in clinical liver preservation. Although a greater 1-year graft and patient survival was observed in the CEL group, a definitive evaluation comparing CEL and HTK solutions in clinical preservation must await completion of the trial.
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