Hypothermia to Treat Severe Brain Injury

Completed · Not applicable

Conditions studied: Brain Injuries, Hypothermia

In brief

The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury improves functional outcome. This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).

Key facts

Study ID

NCT00040339

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

42

Starts

2002-05-01

Expected to finish

2005-07-01

Last updated by the study team

2008-01-08

Who can join

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

You may qualify if…

• GCS 3-8 on initial evaluation or deteriorates during transport
• Mechanism of injury consistent with blunt, non-penetrating trauma to head
• Systolic blood pressure > 110 mm Hg
• Diastolic blood pressure> 60 mm Hg
• Heart rate (pulse) < 120 beats per minute
• Estimated or known age 16-45
• No suspicion of pregnancy
• Esophageal/rectal probe temperature > 35.5°C (Pre-hospital cooling only)
• Injured < 2 hours prior to arrival of pre-hospital providers
• No evidence of severe chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis).

You may not qualify if…

• Following commands upon EMS arrival without deterioration to coma or follows command after an initial period of coma.
• Mechanism of injury GSW or no indication of head injury
• Systolic blood pressure < 120 mm Hg
• Diastolic blood pressure < 60 mm Hg
• Heart rate (pulse) > 120 beats per minute
• Estimated or know age > 45 or < 16
• Suspected pregnancy
• Forehead scan temp < 35.5°C (Pre-hospital cooling only)
• Injured >2 hours prior to arrival of pre-hospital providers
• Evidence of major chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis.
• ELIGIBILITY CRITERIA FOR 48 HOURS OF MODERATE HYPOTHERMIA (33°C):
• Inclusion Criteria:
• Non-penetrating brain injury with a post-resuscitation Glasgow Coma Score < 8 (motor 1-5).
• Exclusion Criteria:
• Glasgow Coma Score = 7 or 8 with a normal CT scan or a CT scan showing only mild subarachnoid hemorrhage or skull fracture.
• Glasgow Coma Score = 3 and bilaterally unreactive pupils.
• AIS >/= 4 for any body area except head.
• Persistent hypotension in the Emergency Department (systolic blood pressure < 90 mmHg for > 30 minutes after arrival).
• Persistent hypoxia (O2 saturation < 94%) for > 30 minutes post resuscitation.
• Unavailable for cooling within four hours of injury.
• Pre-existing medical conditions, if known.

Where it is running

• St. Louis University — St Louis, Missouri, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas-Houston — Houston, Texas, United States
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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