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US transplant study may have violated federal rules

BMJ 2016; 355 doi: (Published 04 November 2016) Cite this as: BMJ 2016;355:i5956
  1. Michael McCarthy
  1. Seattle

A large study assessing whether inducing hypothermia in brain dead organ donors would affect graft function in recipients of kidney transplants may have violated federal regulations by not considering the organ recipients as human participants, an investigation has found.1 The investigation was conducted by the US Department of Veterans Affairs’ Office of Research Oversight.

In the study, published in the New England Journal of Medicine in 2015,2 organ donors, after declaration of neurologic death, were randomly assigned to being cooled to 34°C to 35°C, the “mild hypothermia” group, or to be maintained at 36.5°C to 37.5°C, the “normothermia” group, pending organ harvesting. The trial’s main outcome measure was whether hypothermia reduced the rate of delayed graft function in the organ recipients, defined as the requirement for dialysis in the first week after transplantation.

The trial was terminated early on the recommendation of an independent data and safety monitoring board, after an interim analysis showed efficacy of hypothermia. At …

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