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NCT Number: NCT05166343

POHCA Resuscitation: Evaluation of IM Epinephrine

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).

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Key information

Conditions

Pediatric Out-of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children's Hospital - London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location status: Recruiting

Location contact

Janice Tijssen, MD MSc

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epinephrine Injection

Drug

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 outcomes

  1. Time to initial return of spontaneous circulation (ROSC)

    Time frame: At time of event

    The primary outcome will be the time to initial ROSC. The investigator will compare time to initial ROSC between the standard of care and intervention periods.

Secondary outcomes

  1. Return of spontaneous circulation

    Time frame: At time of event

    Whether return of spontaneous circulation is achieved or not

  2. Time to sustained ROSC

    Time frame: At time of event

    Time to sustained ROSC will be calculated from the time that paramedics arrive on scene to the time that sustained ROSC, defined as chest compressions not required for 20 minutes with persistent signs of circulation, is achieved.

  3. Survival

    Time frame: From time of event to ED admission

    Survival to emergency department transfer to pediatric critical care unit (PCCU), if applicable: admitted to PCCU from external ED

  4. Survival - comparison between both arms

    Time frame: From time of event to hospital admission

    Survival to hospital admission will be compared between standard of care and intervention periods

  5. PCCU/Hospital length of stay

    Time frame: From time of hospital/PCCU admission to discharge, up to 1 year

    PCCU and hospital length of stay will be calculated from time of admission to the PCCU/hospital and time to discharge from PCCU/hospital, if applicable, between standard of care and intervention periods

  6. Survival to hospital discharge

    Time frame: Dependent on course of hospital stay, up to 1 year

    Survival to hospital discharge will be compared between standard of care and intervention periods

  7. Post POHCA survival

    Time frame: Dependent on survival at 6 and 12 month period post POHCA event

    Survival at 6 months and 12 months post-POHCA will be compared between standard of care and intervention periods

  8. Neurological status

    Time frame: From time of discharge and 6 and 12 months post POHCA event

    The investigator will compare PCPC scores at discharge, 6- and 12-months post-POHCA between the standard of care and intervention periods

  9. Life Impact and Pediatric Quality of Life assessments

    Time frame: 6 and 12 months post POHCA event

    Life Impact assessment between 6 and 12 months: the investigator will use the Pediatric Quality of Life (PEDSQoL, Pediatrics Quality of Life) assessment tool at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. The score ranges from 0-100, with higher scores indicating better outcome.

  10. Life Impact and Pediatric Quality of Life assessments

    Time frame: 6 and 12 months post POHCA event

    Life Impact assessment between 6 and 12 months: the investigator will use the Daily Activities Scale at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. This scale is a subscore of the PEDSQoL tool with scores ranging from 0-100, with higher scores indicating better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Maysaa Assaf

CONTACT

[email protected]

519-685-8500 ext. 75548

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)

Acronym: PRIME

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Dec 21, 2021
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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