THAPCA-IH

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Moler FW, et al. "Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children". NEJM. 2017. 376:318-329.
PubMedFull textPDFClinicalTrials.gov

Clinical Question

Among comatose children aged 2 days to 18 years with return of spontaneous circulation (ROSC) after in-hospital cardiac arrest of any cause, does mild hypothermia (32-34ºC) lead to improved neurological outcomes at 12 months as compared to normothermia?

Bottom Line

Among comatose children 2 days to 18 years who survived in-hospital cardiac arrest from any cause, mild therapeutic hypothermia (32-34ºC), as compared with targeted temperature control at normothermia (37ºC), does not improve favorable functional outcome at 12 months.

Major Points

The Therapeutic Hypothermia after Out-of-Hospital Cardiac Arrest in Children (THAPCA-IH) trial was designed to answer the question if mild hypothermia is neuroprotective in children with ROSC after in-hospital cardiac arrest. ... VABS-II score of at least 70 ...

Guidelines

As of July 2021, no guidelines have been published that reflect the results of this trial.

Design

  • Multicenter, double-blind, randomized, controlled trial
  • N=257
    • Intervention (n=)
    • Placebo (n=)
  • Setting: 37 centres in Canada and the United States
  • Enrollment: 295
  • Mean follow-up: 12 months
  • Analysis: Intention-to-treat
  • Primary outcome: Survival with a good neurobehavioral outcome at 12 months (VABS-II score ≥70)

Population

Inclusion Criteria

  • older than 48 hours, less than 18 years
  • cardiac arrest inside hospital walls
  • received chest compressions for minimum 2 minutes
  • remained dependant to mechanical ventilation following ROSC

Exclusion Criteria

  • GCS motor response scale 5 or 6
  • unable to undergo randomization within 6 hours of event
  • Active/refractory bleeding

Baseline Characteristics

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  • Demographics:
  • Physiologic parameters:
  • Anthropomorphics: Weight
  • Labs:
  • Site of infection

Interventions

Outcomes

Comparisons are BLANK therapy vs. BLANK therapy.

Primary Outcomes

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

Funding

  • National Heart, Lung, and Blood Institute

Further Reading