Hypothermia to Treat Severe Brain Injury

NCT00040339 | Completed

• 1 other identifier: R01NS43353
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 5

Brief Summary

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).

Conditions

Brain Injuries; Hypothermia

Keywords

brain injury; hypothermia; body cooling; body temperature

Interventions

hypothermia (body temperature lowered to 33°C or 91.4°F) PROCEDURE

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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):
• Non-penetrating brain injury with a post-resuscitation Glasgow Coma Score \< 8 (motor 1-5).
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (5)

St. Louis University

St Louis, Missouri, 63103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Texas-Houston

Houston, Texas, 77030, United States

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Links

• Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury (NABIS:HIIR) Phase III trial information

MeSH Terms

Conditions

Brain Injuries; Hypothermia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy L. Clifton, M.D.

  Professor and Chair, Department of Neurosurgery, University of Texas-Houston, Houston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 24, 2002
• First Posted: June 25, 2002
• Study Start: May 1, 2002
• Study Completion: July 1, 2005
• Last Updated: January 8, 2008

Record last verified: 2007-12

Locations

US (4); CA (1)