POHCA Resuscitation: Evaluation of IM Epinephrine

Last updated: March 7, 2025
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Epinephrine Injection

Clinical Study ID

NCT05166343
PRIME-1
  • Ages 1-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 1 day to and including 17 years experiencing an out-of-hospitalcardiac arrest (OHCA)

  • Must be receiving at least 1 minute of CPR by trained first responders (police,fire, or paramedic services)

Exclusion

Exclusion Criteria:

  • Children who experience OHCA due to an obvious traumatic event.

Study Design

Total Participants: 284
Treatment Group(s): 1
Primary Treatment: Epinephrine Injection
Phase: 2/3
Study Start date:
January 08, 2024
Estimated Completion Date:
January 31, 2029

Study 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.

Connect with a study center

  • Children's Hospital - London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

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