NCT03261089 Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst
| NCT ID | NCT03261089 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2017-08-02 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2017-08-02 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
David M Greer, MD MA
PRINCIPAL INVESTIGATOR
Boston Medical Center, Neurology
Frequently Asked Questions
Who can join the NCT03261089 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03261089 currently recruiting?
Yes, NCT03261089 is actively recruiting participants. Contact the research team at dgreer@bu.edu for enrollment information.
Where is the NCT03261089 trial being conducted?
This trial is being conducted at San Francisco, United States, New Haven, United States, Gainesville, United States, Boston, United States and 4 additional locations.
Who is sponsoring the NCT03261089 clinical trial?
NCT03261089 is sponsored by Boston Medical Center. The principal investigator is David M Greer, MD MA at Boston Medical Center, Neurology. The trial plans to enroll 600 participants.