Hypothermia to Treat Severe Brain Injury

Brain Injuries Clinical Trial

Official title:

The National Acute Brain Injury Study: Hypothermia II (NABISH II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040339
• Other study ID #: R01NS43353
• Status: Completed
• Phase: N/A
• First received: June 24, 2002
• Last updated: December 26, 2007
• Start date: May 2002
• Est. completion date: July 2005

Study information

• Verified date: December 2007
• Source: National Institute of Neurological Disorders and Stroke (NINDS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Description:

After brain injury, the brain produces certain chemicals that are harmful to the injured tissues. Moderate hypothermia—also called body cooling—may slow or prevent the production of these chemicals. Hypothermia also decreases the amount of oxygen needed by the brain, which may provide some protection during this critical period. Earlier studies have shown that maintenance of moderate hypothermia may have a helpful effect in head injury patients ages 16 to 45 who arrive at the hospital with a low body temperature suggesting that very early cooling may be beneficial.

In this study scientists will initiate hypothermia or body cooling to 35˚C within two hours of severe brain injury to determine if body cooling improves functional outcome.

Patients may enter the study in one of two ways. They may be evaluated and surface cooling begun at the scene by emergency medical services (EMS) personnel affiliated with the study; or patients who arrive in the emergency department (ED) of the study hospital within 2 hours of injury—and who have not already been evaluated by EMS personnel affiliated with the study—will be evaluated and cooling begun, if applicable, by NABISH study personnel.

NABISH-trained EMS personnel who reach a patient with a suspected severe head injury within 2 hours of injury will induce hypothermia to 35˚C at the scene, in transit, or in the ED.

NABISH study personnel will induce hypothermia to 35˚C in the ED in patients with suspected severe head injury who reach the ED within 2 hours of injury if cooling has not already begun. Patients who meet entry criteria (based upon past studies) for moderate hypothermia for 48 hours will then be cooled to 33˚C and then gradually rewarmed after 48 hours at 33˚C. Patients initially cooled to 35˚C within 2 hours of injury who prove during trauma evaluation to have exclusion criteria for 48 hours of moderate hypothermia will be warmed from 35˚C to 37˚C.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

ELIGIBILITY CRITERIA FOR EARLY COOLING TO 35°C:

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hypothermia

Intervention

Procedure:
• hypothermia (body temperature lowered to 33°C or 91.4°F)

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Texas-Houston	Houston	Texas
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	St. Louis University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

External Links

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