The Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials, initiated by the National Heart, Lung, and Blood Institute (NHLBI), will evaluate the effectiveness of therapeutic hypothermia in infants and children who have experienced cardiac arrest.
Therapeutic hypothermia has been successful in adult patients with cardiac arrest and in newborns after birth asphyxia, but its use in the pediatric populations with cardiac arrest has never been studied.
The two controlled clinical trials will take place at 34 sites across the U.S. During them, researchers will study both patients who suffered cardiac arrest outside and inside the hospital.
Both will use two active treatment groups: therapeutic hypothermia (cooling the patient to 89.6-93.2 degrees Fahrenheit) and therapeutic normothermia (maintaining the patient at 96.8-99.5 degrees Fahrenheit).
Patients in the intervention arm will receive hypothermia treatment for two days, while the normothermia treatment arm will receive treatment for three days to ensure that the body temperature is within a normal temperature range.
According to NHLBI, both studies will attempt to reduce fever, which commonly occurs in patients subsequent to cardiac arrest and can lead to more severe outcomes. Additionally, patients will undergo neurological and behavioral testing one-year after cardiac arrest.
Enrolled patients must be older than 48 hours and younger than 18 and must be enrolled into the studies within six hours of suffering cardiac arrest.
"Our goal is to minimize brain injury in infants and children who experience cardiac arrest and ultimately improve survival rates," said co-principal investigator J. Michael Dean, MD, professor of pediatrics and chief of the pediatric critical care division at the University of Utah School of Medicine in Salt Lake City.
C.S. Mott Children’s Hospital at the University of Michigan in Ann Arbor will serve as the trials lead clinical center, while the University of Utah will serve as the trials data coordinating center. The trials are being conducted in conjunction with the Collaborative Pediatric Critical Care Research Network.