Status:
COMPLETED
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiac Arrest
Eligibility:
All Genders
48-18 years
Phase:
NA
Brief Summary
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...
Detailed Description
Cardiac arrest occurs when the heart suddenly stops beating and blood flow to the body is halted. It can occur while people are in the hospital because of a medical condition or while people are out o...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00880087
Start Date
September 1 2009
End Date
February 1 2016
Last Update
June 15 2018
Active Locations (33)
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1
The Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
4
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90028