Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury - Full Text View

Sponsor:	The University of Texas Health Science Center, Houston
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00178711

Purpose

Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months and 12 months after injury compared to patients randomized to normothermia.

Condition	Intervention	Phase
Traumatic Brain Injury	Procedure: Hypothermia	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	National Acute Brain Injury Study: Hypothermia IIR

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

The dichotomized Glasgow Outcome Scale (Good Recovery/Moderate Disability vs. Severe Disability/Vegetative/Dead) [ Time Frame: 6 months with a window of plus or minus one month ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	November 2005
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: hypothermia Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.	Procedure: Hypothermia Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours Other Name: moderate hypothermia
No Intervention: control

Detailed Description:

NABIS:HIIR is a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients will be randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis is used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury. GOS is dichotomized into good outcome (Good Recovery/Moderate Disability) and poor outcome (Severe Disability, Vegetative, Dead).

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5)
Estimated or known age > 16 and < 45 years old
Time of Injury within 2.5hrs of arrival at hospital

Exclusion Criteria:

GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization
GCS = 3 AND bilaterally non-reactive pupils
Abbreviated Injury Score (AIS) > 4 for any body area except head
Positive abdominal ultrasound or CT scan
Persistent hypotension (systolic blood pressure < 110mmHGg)
Persistent hypoxia (O2 Saturation < 94%)
Positive pregnancy test
Injured greater than 2.5 hours from hospital arrival
Pre-existing medical conditions, if known

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178711

Locations

United States, Missouri
University of St Louis : St. Louis University Hospital
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pittsburgh : University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Health Science Center, Memorial Hermann Hospital
Houston, Texas, United States, 77030
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Canada, Alberta
University of Calgary Health Science Center : Foothills Medical Center
Calgary, Alberta, Canada, T2N4N1

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Guy L Clifton, MD

UTHSC-H

More Information

No publications provided by The University of Texas Health Science Center, Houston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Clifton GL, Valadka A, Zygun D, Coffey CS, Drever P, Fourwinds S, Janis LS, Wilde E, Taylor P, Harshman K, Conley A, Puccio A, Levin HS, McCauley SR, Bucholz RD, Smith KR, Schmidt JH, Scott JN, Yonas H, Okonkwo DO. Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial. Lancet Neurol. 2011 Feb;10(2):131-9. Epub 2010 Dec 17.

Responsible Party:	Guy L. Clifton M.D., UTHSC Department of Neurosurgery
ClinicalTrials.gov Identifier:	NCT00178711 History of Changes
Other Study ID Numbers:	S U01 NS043353-02, Grant# 5 U01 NS043353-05
Study First Received:	September 13, 2005
Last Updated:	April 12, 2010
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:

Traumatic Brain Injury
Hypothermia

Additional relevant MeSH terms:

Hypothermia
Brain Injuries
Body Temperature Changes
Signs and Symptoms
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012