Hypothermia in Children After Trauma

Stopped early · Phase 3

Conditions studied: Traumatic Brain Injury

In brief

The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).

Key facts

Study ID

NCT00222742

Run by

Phoenix Children's Hospital

People needed

90

Starts

2007-11-01

Expected to finish

2012-03-01

Last updated by the study team

2012-07-11

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a GCS </= 8
• Glasgow Motor Score < 6
• Closed head injury
• Age 0 < 18 y

You may not qualify if…

• Unavailable to initiate cooling within 6 hours of injury
• Glasgow Coma Scale (GCS) score = 3 and abnormal brainstem function
• Normal initial CT scan (No blood, fracture, swelling, and/or shift)
• Penetrating brain injury
• No known mechanism of injury
• Unknown time of injury
• Uncorrectable coagulopathy (PT/PTT > 16/40 sec, INR > 1.7)
• Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min)
• Documented Hypoxic episode (O2 saturation < 94% for > 30 min)
• Pregnancy

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• University of California, Davis Medical Center — Sacramento, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Cohen's Children's Hospital — New Hyde Park, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pittsburgh/Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas, Southwestern — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States
• Sydney Children's Hospital, Randwick — Sydney, New South Wales, Australia
• Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Royal Children's Hospital, Brisbane — Brisbane, Queensland, Australia
• Mater Children's Hospital — Brisbane, Queensland, Australia
• Children's Youth and Women's Health Service — North Adelaide, South Australia, Australia
• Royal Children's Hospital Melbourne — Parkville, Victoria, Australia
• Princess Margaret Hospital for Children — Subiaco, Perth, Western Australia, Australia
• Stollery Children's Hospital — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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