Therapeutic Hypothermia After Pediatric Cardiac Arrest (In-Hospital) (THAPCA-IH)
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September 2009-February 2016
July 31, 2019
Clinical Trial URLs
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Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
See also the THAPCA-OH study for analogous data regarding out-of-hospital pediatric cardiac arrest.
To evaluate the efficacy of therapeutic hypothermia compared to therapeutic normothermia at increasing 12 month survival rates in comatose infants and children who were resuscitated after an in-hospital cardiac arrest.
Current guidelines recommend either hypothermia or normothermia for temperature management after out-of-hospital cardiac arrest in adults and children. Published results of clinical trials of therapeutic hypothermia versus therapeutic normothermia in adults and children who have had an in-hospital cardiac arrest are lacking. Patients who have experienced an in-hospital cardiac arrest represent a pathophysiologically distinct population from those who have experienced an out-of-hospital arrest, and the potential efficacy of an intervention may differ in the two populations. The THAPCA-IH trial was initiated due to the lack of published results from randomized trials on pediatric populations, and the significant differences that exist regarding cardiac arrest in pediatric and adult populations.
Patients were identified at 37 sites in the United States, Canada, and the UK who met the inclusion criteria. Participants were required to be pediatric patients who experienced a cardiac arrest that began inside the walls of a hospital, which required chest compressions for at least 2 minutes and remained dependent on mechanical ventilation after the return of circulation. Pediatric patient population was defined as being greater than 48 hours and less than 18 years of age. Written informed consent from a parent or legal guardian was obtained for each participant.
In total, 329 participants underwent randomization at 36 sites. 166 participants were assigned to therapeutic hypothermia and 163 participants were assigned to therapeutic normothermia. Of the 329 patients randomized only 257 patients had sufficient pre-arrest neurobehavioral function to be eligible for analysis of the primary efficacy endpoint (survival with VABS-II score of ≥70 at one year).
Selected exclusion criteria includes: Glasgow Coma Scale motor response of 5 or 6, terminal illness, randomization unattainable within 6 hours of return of spontaneous circulation, active and refractory bleeding, a preexisting illness associated with a life expectancy of less than 12 months, and decision(s) by the clinical team to withhold aggressive treatment.
Eligible patients were randomized in a 1:1 ratio within 6 hours after the return of circulation with the use of permuted blocks stratified according to clinical center and age category (<2 years, 2 to 12 years, and ≥12 years).
Patients assigned to therapeutic hypothermia were pharmacologically paralyzed and sedated. A Blanketrol III temperature-management unit was used with blankets applied anteriorly and posteriorly to achieve the target temperature of 33° C ± 1° C. After maintaining the cooled temperature for 48 hours, patients were warmed to 36.8° C ± 0.75° C over a period of at least 16 hours, which was maintained until 120 hours after the cardiac arrest. Patients assigned to therapeutic normothermia received identical care except the core temperature was maintained by the temperature-management unit at 36.8° C ± 0.75° C for 120 hours.
The primary outcome was survival with a good neurobehavioral outcome at 12 months, defined as an age-corrected standard VABS-II score of ≥70, on a scale of 20 to 160. Secondary outcomes were survival at 12 months and change in neurobehavioral function.
The trial was terminated due to futility after 329 patients were randomized. Among the patients who had a VABS-II score of ≥70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group. Among all randomized patients, the change in the VABS-II score from baseline to 12 months was not significantly different and 1-year survival was similar between the groups.
In comatose children who survived in-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year.
Moler FW, Silverstein FS, Holubkov R, et al. Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children. N Engl J Med. 2017;376(4):318–329. doi:10.1056/NEJMoa1610493
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 665.1 KB)
- THAPCA IH Annotated Case Report Forms (PDF - 2.7 MB)
- THAPCA IH Protocol (PDF - 3.4 MB)
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