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Hypothermia to Treat Severe Brain Injury

Primary Purpose

Brain Injuries, Hypothermia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
hypothermia (body temperature lowered to 33°C or 91.4°F)
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring brain injury, hypothermia, body cooling, body temperature

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Louis University
  • University of Cincinnati
  • University of Pittsburgh
  • University of Texas-Houston
  • University of Calgary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 24, 2002
Last Updated
December 26, 2007
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00040339
Brief Title
Hypothermia to Treat Severe Brain Injury
Official Title
The National Acute Brain Injury Study: Hypothermia II (NABISH II)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Hypothermia
Keywords
brain injury, hypothermia, body cooling, body temperature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
hypothermia (body temperature lowered to 33°C or 91.4°F)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy L. Clifton, M.D.
Organizational Affiliation
Professor and Chair, Department of Neurosurgery, University of Texas-Houston, Houston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
University of Texas-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00178711
Description
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury (NABIS:HIIR) Phase III trial information

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Hypothermia to Treat Severe Brain Injury

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