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Updated: Oct 3, 2026
Pre-clinical Model of Cardiac Donation after Circulatory Death
Published on: August 2, 2019
Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized
Glauco A Westphal1,2,3, Caroline Cabral Robinson1, Natalia Elis Giordani1,4
1Responsabilidade Social-Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde (PROADI-SUS), Hospital Moinhos de Vento (HMV), Porto Alegre, Rio Grande do Sul, Brazil.
Insights
An evidence-based checklist for brain-dead potential donors did not significantly reduce cardiac arrest loss. However, high adherence to the checklist showed a significant reduction in donor loss, highlighting the importance of consistent implementation.
Area of Science:
- Intensive care medicine
- Organ donation and transplantation
- Clinical trial methodology
Background:
- Brain-dead potential donors are at risk of cardiac arrest, leading to loss of viable organs.
- The effectiveness of goal-directed care in preventing this loss remains unclear.
Purpose of the Study:
- To evaluate an evidence-based, goal-directed checklist for managing brain-dead potential donors in the ICU.
- To determine if this checklist reduces donor loss to cardiac arrest.
Main Methods:
- A cluster randomized clinical trial (DONORS study) in Brazil involving 63 hospitals.
- Brain-dead potential donors were randomized to receive the checklist intervention or usual care.
- The primary outcome was donor loss due to cardiac arrest.
Main Results:
- The overall use of the checklist did not significantly reduce donor loss (9.4% vs 14.8%).
- However, high adherence (>79.0%) to the checklist was associated with a significant reduction in donor loss (5.3% vs 14.8%).
Conclusions:
- The study was inconclusive on the overall effectiveness of the checklist.
- High adherence to the evidence-based checklist is crucial for reducing brain-dead potential donor loss to cardiac arrest.
Importance:
The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear.
Objective:
To evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU).
Design, Setting, And Participants:
The Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020.
Interventions:
Hospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care.
Main Outcomes And Measures:
The primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group.
Results:
Among the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P = .11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P = .006).
Conclusions And Relevance:
This cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist.
Trial Registration:
ClinicalTrials.gov Identifier: NCT03179020.
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