Hypothermia to Treat Severe Brain Injury

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

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).

Study Overview

Detailed 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).

Study Type

Interventional

Enrollment

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary
    • Missouri
      • St. Louis, Missouri, United States, 63103
        • St. Louis University
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • University of Cincinnati
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas-Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guy L. Clifton, M.D., Professor and Chair, Department of Neurosurgery, University of Texas-Houston, Houston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion

December 7, 2022

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

June 24, 2002

First Submitted That Met QC Criteria

June 24, 2002

First Posted (Estimate)

June 25, 2002

Study Record Updates

Last Update Posted (Estimate)

January 8, 2008

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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