Randomised sham-controlled double-blind trial evaluating remote ischaemic preconditioning in solid organ transplantation: a study protocol for the RIPTRANS trial.Uutela, A., et al.
BMJ Open 2020; 10(11): e038340.
This protocol aims to determine if remote ischaemic preconditioning (RIPC) leads to improvements in function and longevity of transplanted organs in brain-dead organ donors.
Patients will be randomly assigned to either RIPC intervention or sham-intervention.
Brain-dead organ donors
The primary endpoint is the incidence of delayed graft function of renal allografts. The secondary endpoints are short-term functional outcomes of transplanted organs, graft survival and rejection.
This protocol describes a randomised controlled trial designed to answer a longstanding question in transplantation: does remote ischaemic preconditioning improve outcomes following solid organ transplantation? The investigators propose a large (500 patient) multicentre, double blind sham-controlled trial, using a thigh tourniquet in deceased brain-dead donors prior to organ procurement. Primary outcome will be delayed-graft function in resulting kidney allografts, and outcome data for all transplanted organs will be collected. The study is powered to show a reduction in delayed graft function from 25% to 15% - an ambitious but clinically relevant endpoint. Of interest, donor family consent will not be sought (as approved by the local ethics committee). This may be more of a challenge in other settings where donor interventions face greater restriction.
ClinicalTrials.gov - NCT03855722