POHCA Resuscitation: Evaluation of IM Epinephrine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epinephrine Injection.
- Who it may be relevant to
- Registry conditions: Pediatric Out-of-Hospital Cardiac Arrest. Basic parameters: 1 Day — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)
Overview
This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster quasi randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).
Detailed description
IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.
Interventions
- Drug Epinephrine Injection
Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s) and/or pre-filled syringe (exact dose).
Primary outcome measures
- Time to initial return of spontaneous circulation (ROSC) [Time frame: At time of event]
Secondary outcome measures (10)
- Return of spontaneous circulation [Time frame: At time of event]
- Time to sustained ROSC [Time frame: At time of event]
- Survival [Time frame: From time of event to ED admission]
- Survival - comparison between both arms [Time frame: From time of event to hospital admission]
- PCCU/Hospital length of stay [Time frame: From time of hospital/PCCU admission to discharge, up to 1 year]
- Survival to hospital discharge [Time frame: Dependent on course of hospital stay, up to 1 year]
- Post POHCA survival [Time frame: Dependent on survival at 6 and 12 month period post POHCA event]
- Neurological status [Time frame: From time of discharge and 6 and 12 months post POHCA event]
- Life Impact and Pediatric Quality of Life assessments [Time frame: 6 and 12 months post POHCA event]
- Life Impact and Pediatric Quality of Life assessments [Time frame: 6 and 12 months post POHCA event]
Eligibility criteria
Inclusion criteria
- Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA)
- Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services)
Exclusion criteria
\- Children who experience OHCA due to an obvious traumatic event.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- Children's Hospital - London Health Sciences Centre — London
Publications
- Idrees S, Assaf M, Davis M, Garcia-Bournissen F, Loosley J, Miller MR, Tijssen JA. Evaluating intramuscular epinephrine in pediatric out-of-hospital cardiac arrest (the PRIME trial): study protocol for a multi-centre, stepped-wedge cluster quasi-randomized controlled trial. Trials. 2026 Jun 8. doi: 10.1186/s13063-026-09776-3. Online ahead of print. PMID 42260675
Identifiers
NCT: NCT05166343 · PRIME-1