What this study is
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.
Study details
- Official title
- Addressing an Inherent Bias in Neuroprognostication: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
- Sponsor
- Boston Medical Center
- Conditions
- Cardiac Arrest
- Enrolling
- 600 people
- Starts
- 2017-08-02
- Est. completion
- 2027-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Isolated respiratory arrest without concomitant or ensuing cardiac arrest
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
8 openUniversity of California, San Francisco
San Francisco, California, United States
- Edilberto Amorim de Cerqueira, MD · Principal investigator
RecruitingYale University
New Haven, Connecticut, United States
- Emily Gilmore, MD · Principal investigator
- Rachel Beekman, MD · Principal investigator
RecruitingUniversity of Florida
Gainesville, Florida, United States
- Carolina Maciel, MD · Principal investigator
RecruitingBoston Medical Center
Boston, Massachusetts, United States
- Contact617-638-5127dgreer@bu.edu
- David M Greer, MD MA · Principal investigator
RecruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- David Fischer, MD · Principal investigator
Recruiting
3 sites outside the US
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, Brazil
- Pedro Kurtz, MD, PhD · Principal investigator
- Rodrigo Serafim, MD · Principal investigator
RecruitingAlbert Einstein Israelite Hospital
São Paulo, Brazil
- Gisele Sampaio-Silva, MD · Principal investigator
RecruitingHospital das Clinicas Faculdade de Medicina Ribeirao Preto
São Paulo, Brazil
- Octavio Pontes-Neto, MD · Principal investigator
- Millene Camilo, MD · Principal investigator
Recruiting
Study team
Sponsor
Boston Medical Center
Study ID H-36257, H-45526
Principal investigator
David M Greer, MD MA
Boston Medical Center, Neurology
Principal investigator
Gisele Sampaio-Silva, MD
Hospital Israelita Albert Einstein, Neurology
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.