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Published on: April 19, 2019
Personalising Outcomes after Child Cardiac Arrest (POCCA): design and recruitment challenges of a multicentre,
Ericka L Fink1, Robert S B Clark2, Ashok Panigrahy3
1Critical Care Medicine, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA finkel@ccm.upmc.edu.
Insights
This study validates biomarkers for predicting outcomes in children after cardiac arrest. Early challenges were overcome to improve patient recruitment for this ongoing trial.
Area of Science:
- Pediatric critical care medicine
- Biomarker research
- Neurology
Background:
- Paediatric cardiac arrest (PCA) outcomes are variable.
- Predictive biomarkers are needed for personalized treatment.
- Pilot studies suggest blood and imaging biomarkers show promise.
Purpose of the Study:
- To validate clinical, blood, and imaging biomarkers for prognostication in paediatric cardiac arrest.
- To establish a clinically relevant panel of biomarkers.
- To assess survival and functional outcomes at 1 year post-event.
Main Methods:
- An ongoing, multicentre observational trial involving 14 sites.
- Enrollment of 164 children (48 hours to 17 years) admitted to ICU post-cardiac arrest.
- Collection of blood samples (days 1-3) and brain MRI/spectroscopy for biomarker analysis.
Main Results:
- Recruitment challenges were identified and addressed through strategic interventions.
- Patient enrollment has shown improvement.
- Study procedures and biomarker analyses are currently in progress.
Conclusions:
- The trial is actively validating biomarkers for paediatric cardiac arrest prognostication.
- Successful recruitment strategies have been implemented.
- Results will inform personalized outcome prediction in this vulnerable population.
Introduction:
Blood and imaging biomarkers show promise in prognosticating outcomes after paediatric cardiac arrest in pilot studies. We describe the methods and early recruitment challenges and solutions for an ongoing multicentre (n=14) observational trial, Personalising Outcomes following Child Cardiac Arrest to validate clinical, blood and imaging biomarkers individually and together in a clinically relevant panel.
Methods And Analysis:
Children (n=164) between 48 hours and 17 years of age who receive chest compressions irrespective of provider, duration, or event location and are admitted to an intensive care unit are eligible. Blood samples will be taken on days 1-3 for the measurement of brain-focused biomarkers analysed to predict the outcome. Clinically indicated and timed brain MRI and spectroscopy biomarkers will be analysed to predict the outcome. The primary outcome for the trial is survival with favourable (Vineland Adaptive Behavioural Scale score >70) outcome at 1 year. Secondary outcomes include mortality and pre-event and postdischarge measures of emotional, cognitive, physical and family functioning and health-related quality of life. Early enrollment targets were not met due to prolonged regulatory and subcontract processes. Multiple, simultaneous interventions including modification to inclusion criteria, additional sites and site visits were implemented with successful improvement in recruitment. Study procedures including outcomes and biomarker analysis are ongoing.
Ethics And Dissemination:
Twelve of 14 sites will use the centralised Institutional Review Board (IRB) at the University of Pittsburgh (PRO14030712). Two sites will use individual IRBs: Children's Healthcare of Atlanta Institutional Review Board and Children's Hospital of Wisconsin IRB. Parents and/or guardians are consented and children assented (when possible) by the site Primary investigator (PI) or research coordinator for enrollment. Study findings will be disseminated through scientific conferences, peer-reviewed journal publications, public study website materials and invited lectures.
Trial Registration Number:
NCT02769026.
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