Prognostication Biomarkers in Pediatric Cardiac Arrest

NCT02769026 | Completed

• 1 other identifier: 1R01NS096714-01A1
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter study will validate a panel of serum, imaging, and clinical biomarkers to classify patient outcome early after out-of-hospital pediatric cardiac arrest. Results are expected to have a positive and immediate impact in advancing clinical care and outcomes for these children. This work will provide clinicians, families, and researchers with superior tools to assess the severity of brain injury early after resuscitation in order to know who is at risk of brain injury and may benefit from neuroprotective interventions, to monitor response to these interventions, to plan rehabilitation strategy, and to optimize the design of research studies that test novel interventions to improve neurological outcome after cardiac arrest.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Vineland Adaptive Behavioral Scale [VABS] score

  Evaluate serum, imaging, and clinical biomarkers individually and in combined models to classify favorable outcome at 1 year post-CA (Favorable outcome at 1 year post-CA is a VABS score \> 70).

  One year from cardiac arrest

Eligibility Criteria

• Age: 48 Hours - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with cardiac arrest

You may qualify if:

• Children between 2 weeks -17 years of age
• Child had an out of hospital CA: defined as "Cessation of cardiac mechanical activity as confirmed by the absence of signs of circulation. Includes the following rhythms: pulseless electrical activity (PEA), asystole, ventricular tachycardia, and ventricular fibrillation" without a specific duration of CA to capture the full breadth of the range of neurological outcomes
• Children will be admitted to a pediatric or cardiac ICU
• Children have vascular access for blood draws as part of their standard of care
• Children have a pre-CA Pediatric Cerebral Performance Category (PCPC) score of 1-3. 6. The caregivers are required to be fluent in English but some sites may support Spanish-speaking only caregivers

You may not qualify if:

• Patients with acute simultaneous brain lesion (trauma, abscess, tumor, bacterial meningitis)
• Children with do not resuscitate (DNR) status
• Child is pregnant
• Child has an absolute or major contraindication for MRI/S (metal in the eyes, cardiac pacemakers, implanted cardioverter defibrillators, neurostimulation systems, and cochlear implants)
• Child is undergoing brain death evaluation
• Child has metabolic disease affecting the brain

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

• Fink EL, Clark RSB, Panigrahy A, Berger R, Wisnowski J, Bluml S, Maloney D, Rubin P, Haller T, Bayir H, Beers SR, Kochanek PM, Fabio A; POCCA Investigators. Personalising Outcomes after Child Cardiac Arrest (POCCA): design and recruitment challenges of a multicentre, observational study. BMJ Open. 2020 Oct 27;10(10):e039323. doi: 10.1136/bmjopen-2020-039323.

  PMID: 33109667 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and blood clot stored for future biomarker and DNA analysis

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatric Critical Care Medicine

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2017
• Primary Completion: September 30, 2020
• Study Completion: March 1, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

US (1)