Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial

Completed · Not applicable

Conditions studied: Cardiac Arrest

In brief

Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while in the hospital.

Key facts

Study ID

NCT00880087

Run by

University of Michigan

People needed

329

Starts

2009-09-01

Expected to finish

2016-02-01

Last updated by the study team

2018-06-15

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient suffered cardiac arrest requiring chest compressions for at least 2 minutes (120 seconds) with ROSC/ROC; AND
• Age greater than 48 hours (with a corrected gestational age of at least 38 weeks) and less than 18 years; AND
• Patient requires continuous mechanical ventilation; AND
• The cardiac arrest was unplanned (i.e., not part of cardiac surgical procedure)

You may not qualify if…

• The parent or legal guardian does not speak English or Spanish (the only two languages in which VABS II is standardized)
• Randomization is impossible within six hours of ROSC; OR
• Patient is on extracorporeal membrane oxygenation (ECMO) when arrest occurs; OR
• Continuous infusion of epinephrine or norepinephrine at very high doses (≥2 ug/kg/minute) received immediately prior to randomization; OR Glasgow Coma Scale motor response of five (localizing pain or for infants less than two years, withdraws to touch) or six (obeys commands, or for infants, normal spontaneous movement) prior to randomization; OR
• History of a prior cardiac arrest with chest compressions for at least two minutes during the current hospitalization but outside the 6 hour window for randomization; OR
• Pre-existing terminal illness with life expectancy < 12 months; OR
• Lack of commitment to aggressive intensive care therapies including do not resuscitate orders and other limitations to care; OR
• Cardiac arrest was associated with severe brain, thoracic, or abdominal trauma; OR
• Active and refractory severe bleeding prior to randomization; OR
• Near drowning in ice water with patient core temperature ≤32 °C on presentation; OR
• Patient is pregnant; OR
• Patient participation in a concurrent interventional trial whose protocol, in the judgment of the THAPCA investigators, prevents effective application of one or both THAPCA therapeutic treatment arms, or otherwise significantly interferes with carrying out the THAPCA protocol; OR
• Patient is newborn with acute birth asphyxia; OR
• _ Patient cared for in a neonatal intensive care unit (NICU) after arrest (ie, would not be admitted to PICU); OR
• Patient has sickle cell anemia; OR
• Patient known to have pre-existing cryoglobulinemia; OR
• Central nervous system tumor with ongoing chemotherapy or radiation therapy; OR
• Chronic hypothermia secondary to hypovolemic, pituitary, or related condition for which body temperature is consistently below 37 °C ; OR progressive degenerative encephalopathy; OR
• Any condition in which direct skin surface cooling would be contraindicated, such as large burns, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity (NOTE: patients with open chest CPR should be included but placement of cooling mattresses will be modified as needed); OR
• Previous enrollment in the THAPCA Trials.

Where it is running

• The Children's Hospital of Alabama — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Loma Linda University Children's Hospital — Loma Linda, California, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California San Francisco — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Hospital of Atlanta/Emory University — Atlanta, Georgia, United States
• Riley Children's Hospital — Indianapolis, Indiana, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Michigan, Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Duke Children's Hospital — Durham, North Carolina, United States
• Nationwide Children's Hospital in Columbus — Columbus, Ohio, United States
• Penn State Children's Hospital — Hershey, Pennsylvania, United States
• Children's Hospital of Philidelphia — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• LeBonheur Children's Hospital - University of Tennessee at Memphis — Memphis, Tennessee, United States
• Children's Medical Center Dallas — Dallas, Texas, United States
• University of Texas Health Sciences Center of San Antonio — San Antonio, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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