Transplant Trial Watch

The Effect of Steroid Pretreatment of Deceased Organ Donors on Liver Allograft Function: A Blinded Randomized Placebo Controlled Trial.

Amatschek S, Wilflingseder J, et al.

Journal of Hepatology, 56(6):1305-9, 2012.


Aims
To explore whether steroid pre-treatment of liver donors would or not improve early liver allograft function, prevent rejection and prolong survival.

Interventions
1000 mg of methylprednisolone versus placebo given 6 hours before recovery of organs.

Participants
90 deceased organ donors.

Outcomes
The primary outcomes were the serum level of alanine transaminase and aspartate transaminase within the first week after liver transplantation. Other liver specific parameters included gamma glutamyl transpeptidase, alkaline phosphatase, albumin and total bilirubin. The secondary outcomes included graft loss, mortality and biopsy confirmed acute rejection.

Follow-up
3 years

CET Conclusions
Steroid pre-treatment of organ donors did not improve outcomes after liver transplantation in comparison with patients who received a placebo.

Jadad score
5

Data analysis
Per protocol analysis

Allocation concealment
Yes

Quality notes
This is a sub-analysis of a previous publication of the same RCT: Kainz A. Wilflingseder J. Mitterbauer C, et al. Steroid pretreatment of organ donors to prevent postischemic renal allograft failure: a randomized, controlled trial. Annals of Internal Medicine. 153(4): 222-30, 2010. The methodological quality assessment was based on the previous publication.

Trial registration
ISRCTN78828338 (ISRCTN)

Funding source
Non-industry funded