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NCT Number: NCT03261089

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

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto D'Or de Pesquisa e Ensino, Rio de Janeiro, Brazil

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About this study

SPARE is a multi-center, international, prospective registry designed to evaluate the use of a multi-modality approach to neuroprognostication after cardiac arrest. Subjects will be evaluated with standard, accepted, and widely available assessment modalities, including clinical examination, neurophysiologic (electroencephalography and evoked potentials (per site standard of care), serum biomarkers (per site standard of care), and neuroimaging testing.

The purpose of this study is to collect data from a prospective large-scale cohort involving cardiac arrest survivors, and the clinical characteristics and prognostic features that affect their neurologic outcome. The ultimate goal is to derive a prediction model for neuroprognostication in cardiac arrest, using multiple clinical modalities that are already clinically in use, but in a standardized fashion. We hypothesize that by using a multimodal approach combining clinical assessment tools obtained at standardized time points, we will improve the accuracy of neuroprognostication in initially unconscious cardiac arrest survivors. The US and non-US populations will be compared, as the non-US population is less exposed to early WLST, thus eliminating the self-fulfilling prophecy bias that has plagued all CA studies to date.

Outcomes will be assessed at discharge, at 3 months post-arrest, 6 months, and annually up to 5 years afterwards. The primary outcome will be the proportion of subjects with good versus poor outcome, with a dichotomized approach of the modified Rankin Scale (mRS): good outcome defined as mRS scores of 0-3, and poor outcome as mRS scores of 4-6. Secondary outcome measures include overall scores on the Cerebral Performance Category Scale (CPC), Cerebral Performance Category - Extended (CPC-E), and Montreal Cognitive Assessment (MOCA) (or Telephone Montreal Cognitive Assessment (T-MOCA)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Isolated respiratory arrest without concomitant or ensuing cardiac arrest

Treatment and study plan

Primary outcomes

  1. modified Rankin Score (mRS)

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

    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

Secondary outcomes

  1. Cerebral Performance Category Scale (CPC)

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

    A scale from 1-5 assessing brain function and used to gauge neurological recovery. CPC 1 or 2 is considered good outcome while CPC 3-5 is considered poor outcome

  2. Cerebral Performance Category- Extended (CPC-E)

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

    An advanced multi-domain tool used to assess the detailed neurological and functional recovery.

  3. Montreal Cognitive Assessment (MOCA)

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

    A Screening tool for cognitive impairment. Score from 0-30

  4. Short Form 36

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

    A 36 item patient reported survey used to measure health status and quality of life.

  5. Glasgow Outcome Scale-Extended (GOS-E)

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

    An 8-point scale used to measure global disability and functional outcome

Study contacts

Contact information is provided by the study sponsor or research team.

David M Greer, MD MA

CONTACT

[email protected]

(617) 638-5102

Rebecca Stafford, BA

CONTACT

[email protected]

617-414-2422

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SPARE

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2017
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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