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NCT03261089 · ClinicalTrials.gov registry record
Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
A clinical trial of Cardiac Arrest, sponsored by Boston Medical Center.
- Recruiting
- Registry status
- 600
- Enrollment target
- 8
- Study locations
NCT03261089: Recruiting study of Cardiac Arrest, sponsored by Boston Medical Center.
NCT03261089 is a study of Cardiac Arrest that is actively recruiting participants, run by Boston Medical Center. The registered enrollment target is 600 participants, below the 1,461-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (59% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03261089, a study of Cardiac Arrest, is actively recruiting participants, sponsored by Boston Medical Center.
- RECRUITING
- Registry status
- 600 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Study Locations (8)
Other
- Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro
- Albert Einstein Israelite Hospital - São Paulo
- Hospital das Clinicas Faculdade de Medicina Ribeirao Preto - São Paulo
California
- University of California, San Francisco - San Francisco
Connecticut
- Yale University - New Haven
Florida
- University of Florida - Gainesville
Massachusetts
- Boston Medical Center - Boston
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2017-08-02 |
| Est. Completion | 2027-08 |
What NCT03261089 shows while recruiting
NCT03261089 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 1,461-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Cardiac Arrest appearing as the primary indexed condition, and to 0 interventions.
NCT03261089 lists 8 locations in 6 states (Other, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT03261089 about?
NCT03261089 is a clinical study titled "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...
What is the current status of trial NCT03261089?
This trial is currently recruiting. The enrollment target is 600 participants. The study started on 2017-08-02. Estimated completion is 2027-08.
What conditions does trial NCT03261089 study?
This clinical trial studies the following conditions: Cardiac Arrest.
Who is sponsoring clinical trial NCT03261089?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03261089 being conducted?
This trial has 8 study locations across California, Connecticut, Florida, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiac Arrest
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03261089's enrollment target sits among peer trials
600 9th of 31 higher than 23 of 31 other Cardiac Arrest trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Arrest trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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