Oxygen Persufflation as Adjunct in Liver Preservation (OPAL): Study Protocol for a Randomized Controlled Trial.
Minor T, Putter C, et al.Trials. 12(1): 234, 2011.
Aims
Demonstrate the efficacy of short-term oxygen persufflation in liver preservation to improve early graft recovery after liver transplantation.
Interventions
Liver graft preserved by 2 hours of oxygen persufflation immediately prior to transplantation versus the standard procedure (cold storage without further intervention).
Participants
116 liver transplant patients.
Outcomes
Primary endpoint will be the peak transaminase serum level during the first three days after transplantation. Other outcomes include patient and graft survival, time of intensive care requirement, hepatic tissue perfusion 1hr after revascularisation, and early onset of graft dysfunction based on coagulation parameters.
Follow-up
3 months
CET Conclusions
This is a study protocol in which patients who are to receive a liver transplant will be randomised to receive livers preserved using 2 hours of oxygen persufflation in comparison to standard cold storage with no additional intervention. Peak transaminase during the first 3 days after transplantation will be the primary end point.
Quality notes
This is a study protocol and therefore a quality assessment is not appropriate.
Trial registration
ISRCTN00167887 (ISRCTN)