Transplant Trial Watch

Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial.

Westphal, G. A., et al.

JAMA Network Open 2023; 6(12): e2346901.

This study aimed to investigate the whether an evidence-based, goal-directed checklist was effective in delaying cardiac arrest in brain-dead potential donors in the intensive care unit (ICU).

At cluster level, eligible hospitals were randomised to provide either checklist guidance or usual care. At individual level, potential organ donors were randomised to receive either checklist guidance or usual care.

At cluster level, hospitals with a mean number of ≥ 10 brain-dead potential donors annually over the previous 2 years were eligible. At individual level, brain dead organ donors in the ICU (aged 14 to 90 years) were enrolled.

The primary endpoint was the loss of brain-dead potential donors to cardiac arrest. The secondary endpoints included the conversion of brain-dead potential donors to actual organ donors and the number of solid organs recovered per actual organ donor.

14 days or until transfer from the ICU to the operating room

CET Conclusions
Potential brain-dead organ donors are frequently lost to cardiac arrest prior to organ retrieval. This unblinded randomised trial investigated the efficacy of employing an ICU-based checklist to optimise donor physiology to reduce the rate of donor loss. The checklist included various aspects of critical care management and was randomised to 743 patients (vs. 792 controls). Although there was a numerical improvement in the intervention group, there was no significant difference in rate of donor loss between the two groups. There are several important confounders that are not controlled for in this trial, but the most important limitation is due to the lack of blinding. ICU units in the control arm could have improved their practice in response to being included in such a trial, negating any potential effect due to the intervention.

Jadad score

Data analysis
Strict intention-to-treat analysis

Allocation concealment

Trial registration - NCT03179020

Funding source
Non-industry funded