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

Summary

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.

Conditions

• Cardiac Arrest

Sponsors & Collaborators

• University of Florida

  collaborator OTHER

• Hospital Israelita Albert Einstein

  collaborator OTHER

• Faculty of Medicine of Ribeirão Preto (FMRP-USP)

  collaborator OTHER

• University of Sao Paulo General Hospital

  collaborator OTHER

• Yale University

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• D'Or Institute for Research and Education

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Boston Medical Center

  lead OTHER

Principal Investigators

• David M Greer, MD MA · Boston Medical Center, Neurology

• Gisele Sampaio-Silva, MD · Hospital Israelita Albert Einstein, Neurology

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-02

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• United States
• Brazil

Study Locations