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Clinical trialNCT03261089RecruitingObservational

Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst

SponsorBoston Medical CenterEnrollment600Cardiac Arrest
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil
  • Instituto D'Or de Pesquisa E Ensino

    Rio de Janeiro, Brazil

    Pedro Kurtz, MD, PhDRodrigo Serafim, MD
    Recruiting
  • Albert Einstein Israelite Hospital

    São Paulo, Brazil

    Gisele Sampaio-Silva, MD
    Recruiting
  • Hospital Das Clinicas Faculdade de Medicina Ribeirao Preto

    São Paulo, Brazil

    Millene Camilo, MDOctavio Pontes-Neto, MD
    Recruiting
United States
  • University of California, San Francisco

    San Francisco, California, United States

    Edilberto Amorim de Cerqueira, MD
    Recruiting
  • Yale University

    New Haven, Connecticut, United States

    Emily Gilmore, MDRachel Beekman, MD
    Recruiting
  • University of Florida

    Gainesville, Florida, United States

    Carolina Maciel, MD
    Recruiting
  • Boston Medical Center

    Boston, Massachusetts, United States

    David M Greer, MD MA
    Recruiting
  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

    David Fischer, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
2 Aug 2017
Primary completion
31 Aug 2027
Completion
31 Aug 2027
Last update posted
24 Dec 2025
Registered enrollment
600
Registry id
NCT03261089

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.