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

Conditions

• Cardiac Arrest

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Aug 2, 2017

Status verified

Dec 2025

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

600 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

modified Rankin Score (mRS) [ Time Frame: 14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards ]

Central Contacts

• David M Greer, MD MA
  (617) 638-5102
  [email protected]
• Rebecca Stafford, BA
  617-414-2422
  [email protected]

Locations (5)

Find similar trials in San Francisco, CA

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