Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
NCT ID: NCT03261089
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2017-08-02
2027-08-31
Brief Summary
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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.
Detailed Description
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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)).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Sustained return of spontaneous circulation (ROSC) as defined by maintained spontaneous circulation for at least 20 minutes after cardiopulmonary resuscitation.
Exclusion Criteria
18 Years
89 Years
ALL
No
Sponsors
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University of Florida
OTHER
Hospital Israelita Albert Einstein
OTHER
Faculty of Medicine of Ribeirão Preto (FMRP-USP)
OTHER
University of Sao Paulo General Hospital
OTHER
Yale University
OTHER
University of Pennsylvania
OTHER
University of California, San Francisco
OTHER
D'Or Institute for Research and Education
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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David M Greer, MD MA
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, Neurology
Gisele Sampaio-Silva, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Israelita Albert Einstein, Neurology
Locations
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University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, , Brazil
Albert Einstein Israelite Hospital
São Paulo, , Brazil
Hospital das Clinicas Faculdade de Medicina Ribeirao Preto
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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H-36257, H-45526
Identifier Type: -
Identifier Source: org_study_id