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Addressing an Inherent Bias in Neuroprognostication: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Connecticut
Yale University
RECRUITING
New Haven
Florida
University of Florida
RECRUITING
Gainesville
Massachusetts
Boston Medical Center
RECRUITING
Boston
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Other Locations
Brazil
Instituto D'Or de Pesquisa e Ensino
RECRUITING
Rio De Janeiro
Albert Einstein Israelite Hospital
RECRUITING
São Paulo
Hospital das Clinicas Faculdade de Medicina Ribeirao Preto
RECRUITING
São Paulo
Contact Information
Primary
David M Greer, MD MA
dgreer@bu.edu
(617) 638-5102
Backup
Rebecca Stafford, BA
Rebecca.Stafford@bmc.org
617-414-2422
Time Frame
Start Date: 2017-08-02
Estimated Completion Date: 2027-08
Participants
Target number of participants: 600
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Sao Paulo General Hospital, Yale University, University of Florida, D'Or Institute for Research and Education, Faculty of Medicine of Ribeirão Preto (FMRP-USP), University of California, San Francisco, Hospital Israelita Albert Einstein, National Institute of Neurological Disorders and Stroke (NINDS), University of Pennsylvania
Leads: Boston Medical Center

This content was sourced from clinicaltrials.gov