The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation.
Barthel, E, Rauchfuss F, et al.BMC Surgery 2013; 13(1): 1.
Aims
This study protocol is designed to assess the effect of prostaglandin Iâ‚‚ (PGIâ‚‚) intravenous analogue iloprost on liver graft function.
Interventions
The groups are administered with intravenous iloprost or placebo 10 µg/ml following ICU admission after liver transplantation, within 3 hours of reperfusion.
Participants
356 liver transplant recipients, 18 years and above.
Outcomes
The primary outcome was primary graft dysfunction (ALAT or ASAT level .2000 IU/ml within the first 7 postoperative days; bilirubin ≥10mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non function which was defined as graft loss, retransplantation or patient death within 14 days after initial liver transplant). Secondary outcomes include the rate of initial non function, incidence of infectious complications up to 28 days, graft and patient survival, clotting factor substitution up to day 28 after liver transplantation, the requirement for liver dialysis, post oper
Follow-up
12 months.
CET Conclusions
This protocol describes a double-blinded, placebo controlled study in liver transplantation. The study will evaluate the effect of iloprost administered intravenously within three hours of reperfusion. An infusion lasting seven days is administered with an infusion pump. The primary outcome is primary dysfunction. The study is adequately powered and will use intention to treat analysis. A single centre pilot study from the same group has already been published.
Quality notes
As this paper is a protocol, it has not been quality assessed.
Trial registration
German Clinical Trials Register: DRKS00003514 and Current Controlled Trial Register: ISRCTN12622749