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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorBoston Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Unresponsive patients post-cardiac arrest

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Unresponsive patients post-cardiac arrest

Trial outcomes

Primary outcomes

1

modified Rankin Score (mRS)

A 7-point scale that measures the level of disability or impairment. mRS 0-3 is considered a good outcome while mRS is considered a poor outcome

Time frame
14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

Secondary outcomes

1

Cerebral Performance Category Scale (CPC)

A scale from 1-5 assessing brain function and used to gauge neurological recovery. CPC 1 or 2 is considered good outcome while CPC 3-5 is considered poor outcome

Time frame
14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
2

Cerebral Performance Category- Extended (CPC-E)

An advanced multi-domain tool used to assess the detailed neurological and functional recovery.

Time frame
14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
3

Montreal Cognitive Assessment (MOCA)

A Screening tool for cognitive impairment. Score from 0-30

Time frame
14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards
4

Short Form 36

A 36 item patient reported survey used to measure health status and quality of life.

Time frame
14 days, 3 months post-arrest, 6 months, and annually up to 5 years afterwards

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

University of Florida

Collaborator

Hospital Israelita Albert Einstein

Collaborator

Faculty of Medicine of Ribeirão Preto (FMRP-USP)

Collaborator

University of Sao Paulo General Hospital

Collaborator

Yale University

Collaborator

University of Pennsylvania

Collaborator

University of California, San Francisco

Collaborator

D'Or Institute for Research and Education

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator