EBM Consult

Search by Outline Set Search Limits Advanced Search Back Home

THAPCA Trial: Therapeutic Hypothermia after Out-of-Hospital Cardiac Arrest in Children

Summary:

  • This was a prospective, multicenter, randomized clinical trial at 38 PICUs in the U.S. and Canada involving 295 children < 18 yrs of age who experienced out-of-hospital cardiac arrest and either underwent graded therapeutic hypothermia for 120 hrs or received normal care.
  • This trial did not find a significant benefit in the primary outcome (in the context of survival with good functional outcome at 1 year) was found in those receiving therapeutic hypothermia in this study.
  • However, more patients were alive in the therapeutic hypothermia but was a secondary outcome and a potential smaller clinical benefit might be seen with a larger study.

THAPCA Trial Details
  • Moler F et al. Therapeutic hypothermia after out-of-hospital cardiac arrest in children. N Engl J Med 2015;372(19):DOI: 10.1056/NEJMoa1411480. PubMed
    collapse ▲
    Level of Evidence 1b
    Study Design Propsective, Multicenter, Randomized, Clinical Trial
    Sample Size n= 295
    Population Children < 18 yrs of age
    Inclusion Criteria Children older than 48 hrs but < 18 yrs of age in cardiac arrest requiring chest compressions for at least 2 minutes and remained dependent on mechanical ventilation after the return of circulation.
    Exclusion Criteria The main exclusion criteria were:
    • Inability to be randomized within 6 hrs after the return of circulation
    • GCS = 5 or 6 for motor-response subscale
    • Decision by the clinical team to withhold aggressive treatment
    • Major trauma associated with the cardiac arrest
    Interventions
    • n = 155; Receive Blanketrol III temperature management unit (Cincinnati Sub-Zero) applied anteriorly & posteriorly to a core temperature of 33.0°C (range, 32.0 to 34.0) x 48 hrs, then undergo rewarming x 16 hrs or longer to a target temperature of 36.8°C (range, 36.0 to 37.5) which was actively maintained throughout the remainder of the 120-hrs.
    • n = 140; Received identical care except that the core temperature was actively maintained with the cooling unit at 36.8°C (range, 36.0 to 37.5) x 120 hrs.
    Follow Up 12 months
    Primary Endpoint Survival with a good neurobehavioral outcome at 12 months of follow-up which was defined as an age-corrected standard score of 70 or higher on a scale of 20 to 160 on the Vineland Adaptive Behavior Scales, 2nd ed (VABS-II).
    Secondary Endpoint Survival 12 months after cardiac arrest and change in neurobehavioral function, measured as the difference between the baseline level before cardiac arrest and the 12-month measurement on the VABS-II.  Changes in global cognitive score.
    Results
    • No significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% CI, 0.86 to 2.76; P=0.14).
    • The change in the VABS-II score from baseline to 12 months was not significantly different (P=0.13).
    • 1-yr survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P=0.13).
    • The groups had similar incidences of infection, serious arrhythmias, use of blood products, and 28-day mortality.
    Conclusions Children presenting with out-of-hospital cardiac arrest with return of circulation but comatose did not receive a significant benefit from therapeutic hypothermia in the context of survival with good functional outcome at 1 year.
    Location 38 PICUs in the U.S. and Canada
    Funding National Heart, Lung, and Blood Institute
    ClinicalTrials.gov NCT00878644

MESH Terms & Keywords

  • Pediatric Therapeutic Hypothermia, Post-Cardiac Arrest Therapeutic Hypothermia, Therapeutic Hypothermia in Children

Copyright EBM Consult, LLC

About Us | Disclaimer | Contact Us

Submit a Comment | Submit a Topic | How to Search