Cardiac ArrestSPARENCT03261089
Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
An observational study of Cardiac Arrest, run by Boston Medical Center at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cardiac Arrest
- How many people
- 600 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 2 Aug 2017to Aug 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unresponsive patients post-cardiac arrest
Who may be able to join
- 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.
Who cannot join
- Isolated respiratory arrest without concomitant or ensuing cardiac arrest
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
617-638-5127, dgreer@bu.edu
David M Greer, MD MA
- Recruiting
University of Florida
Gainesville, Florida, 32611
Carolina Maciel, MD
- Recruiting
Yale University
New Haven, Connecticut, 06510
Emily Gilmore, MD
Rachel Beekman, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
David Fischer, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Edilberto Amorim de Cerqueira, MD
Brazil3 sites, 3 recruiting
- Recruiting
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, 22281-100
Pedro Kurtz, MD, PhD
Rodrigo Serafim, MD
- Recruiting
Albert Einstein Israelite Hospital
São Paulo, 05652-900
Gisele Sampaio-Silva, MD
- Recruiting
Hospital das Clinicas Faculdade de Medicina Ribeirao Preto
São Paulo, 14015-010
Octavio Pontes-Neto, MD
Millene Camilo, MD
About this study
Official title: Addressing an Inherent Bias in Neuroprognostication: 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:
Read more
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.
Read the detailed description
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)).
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, neuroprognostication, coma
- Medical subject headings
- Heart Arrest, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Secondary outcomes (5)
Cerebral Performance Category Scale (CPC)
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
Measured: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Cerebral Performance Category- Extended (CPC-E)
An advanced multi-domain tool used to assess the detailed neurological and functional recovery.
Measured: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Montreal Cognitive Assessment (MOCA)
A Screening tool for cognitive impairment. Score from 0-30
Measured: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Short Form 36
A 36 item patient reported survey used to measure health status and quality of life.
Measured: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Glasgow Outcome Scale-Extended (GOS-E)
An 8-point scale used to measure global disability and functional outcome
Measured: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start2 Aug 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Hospital Israelita Albert Einstein, Faculty of Medicine of Ribeirão Preto (FMRP-USP), University of Sao Paulo General Hospital, Yale University, University of Pennsylvania, University of California, San Francisco, D'Or Institute for Research and Education, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- David M Greer, MD MA, Principal investigator, Boston Medical Center, NeurologyGisele Sampaio-Silva, MD, Principal investigator, Hospital Israelita Albert Einstein, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261089
- Sponsor's protocol ID
- H-36257, H-45526
- Other IDs
- R01NS128342
- Acronym
- SPARE
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2017
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing an Inherent Bias in Neuroprognostication: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
- ClinicalTrials.gov ID
- NCT03261089
- Acronym / sponsor ID
- SPARE / H-36257, H-45526
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, neuroprognostication, coma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Florida, Hospital Israelita Albert Einstein, Faculty of Medicine of Ribeirão Preto (FMRP-USP), University of Sao Paulo General Hospital, Yale University, University of Pennsylvania, University of California, San Francisco, D'Or Institute for Research and Education, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresponsive patients post-cardiac arrest
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Isolated respiratory arrest without concomitant or ensuing cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Cerebral Performance Category Scale (CPC)
Time frame: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Cerebral Performance Category- Extended (CPC-E)
Time frame: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Montreal Cognitive Assessment (MOCA)
Time frame: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Short Form 36
Time frame: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David M Greer, MD MA principal investigator
Boston Medical Center, Neurology
Gisele Sampaio-Silva, MD principal investigator
Hospital Israelita Albert Einstein, Neurology
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Boston Medical Center at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David M Greer, MD MA ((617) 638-5102, dgreer@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Score (mRS) (time frame: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.