Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
Recruiting now
Conditions studied: Cardiac Arrest
In brief
Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging. The primary study objective of SPARE is to assess the value of using a systematic, multi-modal approach for neuroprognostication in the unconscious post-cardiac arrest population. We hypothesize that prognostication using this approach will be significantly improved compared to historical controls. This approach will be novel because: All patients who are unconscious at least 24 hours post-cardiac arrest, whereas previous studies on neurologic outcome tended to have restrictive inclusion criteria, such as no pre-existing neurologic impairment (e.g. dementia or prior cerebrovascular injury), or included an unduly restrictive population, such as patients with a strictly comatose state. The prognostic modalities used to assess patients will be applied at specific time points that will maximize their utility. Patients' families and clinicians will be encouraged to provide adequate time to allow for a delayed recovery, especially in cases of uncertain outcome, thus minimizing the self-fulfilling prophesy bias of early withdrawal of life-sustaining therapies (WLST). This will be particularly pertinent in the comparison of US and Brazil/Italy patients, as the Brazilian and Italian populations are not commonly exposed to premature WLST (as can be the case in the US), one of the major sources of biases in prognostication studies of cardiac arrest due to the self-fulfilling prophecy.
Key facts
- Study ID
- NCT03261089
- Run by
- Boston Medical Center
- People needed
- 600
- Starts
- 2017-08-02
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2025-12-24
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Initially unconscious following cardiac arrest from any non-perfusing rhythm (i.e., ventricular tachycardia, ventricular fibrillation, pulseless electrical activity, asystole)
- Sustained return of spontaneous circulation (ROSC) as defined by maintained spontaneous circulation for at least 20 minutes after cardiopulmonary resuscitation.
You may not qualify if…
- Isolated respiratory arrest without concomitant or ensuing cardiac arrest
Where it is running
- University of California, San Francisco — San Francisco, California, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- University of Florida — Gainesville, Florida, United States (enrolling)
- Boston Medical Center — Boston, Massachusetts, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Instituto D'Or de Pesquisa e Ensino — Rio de Janeiro, Brazil (enrolling)
- Albert Einstein Israelite Hospital — São Paulo, Brazil (enrolling)
- Hospital das Clinicas Faculdade de Medicina Ribeirao Preto — São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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