Monitoring Organ Donors to Improve Transplantation Results (MOnIToR) trial methodology.

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