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Status:

TERMINATED

Hypothermia in Children After Trauma

Lead Sponsor:

Phoenix Children's Hospital

Collaborating Sponsors:

National Institutes of Health (NIH)

Conditions:

Traumatic Brain Injury

Eligibility:

All Genders

Up to 17 years

Phase:

PHASE3

Brief Summary

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)...

Detailed Description

The primary specific aim of this RCT is to determine the effect of induced moderate HYPO (32-33 °C) after severe TBI in children on mortality at 3 months post injury. The primary outcome measure will ...

Eligibility Criteria

Inclusion

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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2012

    Estimated Enrollment :

    90 Patients enrolled

    Trial Details

    Trial ID

    NCT00222742

    Start Date

    November 1 2007

    End Date

    March 1 2012

    Last Update

    July 11 2012

    Active Locations (30)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (30 locations)

    1

    Phoenix Childrens Hospital

    Phoenix, Arizona, United States, 85016

    2

    University of California, Davis Medical Center

    Sacramento, California, United States, 95817

    3

    Children's National Medical Center

    Washington D.C., District of Columbia, United States, 20010

    4

    University of Miami

    Miami, Florida, United States, 33136