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

NCT03261089 | Recruiting DMC

• 2 other identifiers: H-36257, H-45526R01NS128342
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 8

Brief 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

Keywords

cardiac arrest; neuroprognostication; coma

Outcome Measures

Primary Outcomes (1)

• modified Rankin Score (mRS)

  A 7-point scale that measures the level of disability or impairment. mRS 0-3 is considered a good outcome while mRS is considered a poor outcome

  14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

Secondary Outcomes (5)

• Cerebral Performance Category Scale (CPC)

  14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

• Cerebral Performance Category- Extended (CPC-E)

  14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

• Montreal Cognitive Assessment (MOCA)

  14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

• Short Form 36

  14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

• Glasgow Outcome Scale-Extended (GOS-E)

  14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

Study Arms (1)

Unresponsive patients post-cardiac arrest

As early as possible post-resuscitation, patients should undergo a detailed neurologic examination, comprised of a thorough assessment for consciousness and detailed cranial nerve function and motor response assessments. Neurologic assessment scores such as the Full Outline of Unresponsiveness, Glasgow Coma Scale (GCS), and Pittsburgh Cardiac Arrest Category (PCAC) Score will be also be used. On the first assessment (day of cardiac arrest), the PCAC score should be assigned only on the basis of the best neurologic exam in the first 6 hours after ROSC. Patients that are sedated or intubated will have the verbal score of GCS be estimated by a derivation of motor and eye scores. The presence of potential confounders, including core body temperature, medications, and/or intoxicants, as well as metabolic derangements will be noted.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unresponsive patients post-cardiac arrest

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

Sponsors & Collaborators

• University of Florida: collaborator
• Faculty of Medicine of Ribeirão Preto (FMRP-USP): collaborator
• University of Sao Paulo General Hospital: collaborator
• Yale University: collaborator
• University of Pennsylvania: collaborator
• University of California, San Francisco: collaborator
• D'Or Institute for Research and Education: collaborator
• Boston Medical Center: lead
• Hospital Israelita Albert Einstein: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Instituto D'Or de Pesquisa e Ensino

Rio de Janeiro, 22281-100, Brazil

RECRUITING

Albert Einstein Israelite Hospital

São Paulo, 05652-900, Brazil

RECRUITING

Hospital das Clinicas Faculdade de Medicina Ribeirao Preto

São Paulo, 14015-010, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Coma

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David M Greer, MD MA

  Boston Medical Center, Neurology

  PRINCIPAL INVESTIGATOR

• Gisele Sampaio-Silva, MD

  Hospital Israelita Albert Einstein, Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Greer, MD MA

CONTACT

(617) 638-5102; dgreer@bu.edu

Rebecca Stafford, BA

CONTACT

617-414-2422; Rebecca.Stafford@bmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 24, 2017
• Study Start: August 2, 2017
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3); US (5)