Registry and tissue repository for comatose cardiac arrest patients
Addressing an Inherent Bias in Neuroprognostication: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
This study is trying to find a way to better predict how well comatose patients will recover after a cardiac arrest by collecting important information about their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT03261089 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a reliable assessment algorithm for predicting neurological outcomes in comatose patients following cardiac arrest. It will collect extensive data on demographics, cardiac arrest details, post-resuscitation care, and various prognostic assessments at standardized time points. The study will involve an international cohort, with a derivation subset for creating a prediction model and a validation subset to confirm its accuracy. Additionally, it will explore the impact of life-sustaining therapy withdrawal practices on outcome predictions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are initially unconscious after experiencing a cardiac arrest from a non-perfusing rhythm.
Not a fit: Patients younger than 18 years or those who experienced isolated respiratory arrest without cardiac arrest will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the ability to predict neurological outcomes in comatose cardiac arrest survivors, guiding better patient management.
How similar studies have performed: Other studies have shown promise in using multimodal prognostic assessments for similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 7 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Instituto D'Or de Pesquisa e Ensino — Rio de Janeiro, Brazil (Recruiting)
- Albert Einstein Israelite Hospital — São Paulo, Brazil (Recruiting)
- Hospital das Clinicas Faculdade de Medicina Ribeirao Preto — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: David M Greer, MD MA — Boston Medical Center, Neurology
- Study coordinator: David M Greer, MD MA
- Email: dgreer@bu.edu
- Phone: (617) 638-5102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.