Background: Despite efforts to increase organ donation, there remain critical shortages in organ donors and organs procured per donor. Our trial is a large-scale, multicentre, randomised controlled trial in brain-dead donors, to compare protocolised care (using minimally invasive haemodynamic monitoring) with usual care. We describe the study design and discuss unique aspects of doing research in this population.
Methods: Our study will randomise brain-dead patients to protocolised or usual care. The primary end point is the number of organs transplanted per donor. Secondary end points include number of transplantable organs per donor, recipient 6-month hospital-free survival time, and the relationship between the level of interleukin-6 and the number and usability of organs transplanted. The primary analysis will be an intention-to-treat analysis; secondary analyses include modified intention-to-treat and as-treated analyses. The study will also compare the ratio of observed to expected number of organs transplanted per donor, by treatment arm, as a secondary end point. Preplanned subgroup analyses include restriction to extended criteria donors, and donors older or younger than 65 years.
Results and conclusions: Several unique challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the fields of organ donation and transplantation.
Trial registration: ClinicalTrials.gov NCT00987714.