Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Stopped early · Phase 3

Conditions studied: Traumatic Brain Injury

In brief

Induction of hypothermia to \< 35˚C by \< 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.

Key facts

Study ID

NCT00178711

Run by

The University of Texas Health Science Center, Houston

People needed

232

Starts

2005-11-01

Expected to finish

2009-12-01

Last updated by the study team

2014-09-17

Who can join

Age: 16 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5)
• Estimated or known age > 16 and < 45 years old
• Time of Injury within 2.5hrs of arrival at hospital

You may not qualify if…

• GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization
• GCS = 3 AND bilaterally non-reactive pupils
• Abbreviated Injury Score (AIS) > 4 for any body area except head
• Positive abdominal ultrasound or CT scan
• Persistent hypotension (systolic blood pressure < 110mmHGg)
• Persistent hypoxia (O2 Saturation < 94%)
• Positive pregnancy test
• Injured greater than 2.5 hours from hospital arrival
• Pre-existing medical conditions, if known

Where it is running

• University of St Louis : St. Louis University Hospital — St Louis, Missouri, United States
• University of Pittsburgh : University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Texas Health Science Center, Memorial Hermann Hospital — Houston, Texas, United States
• Charleston Area Medical Center — Charleston, West Virginia, United States
• University of Calgary Health Science Center : Foothills Medical Center — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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