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Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury (NABIS:HIIR)

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hypothermia
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Hypothermia

Eligibility Criteria

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

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

Sites / Locations

  • University of St Louis : St. Louis University Hospital
  • University of Pittsburgh : University of Pittsburgh Medical Center
  • University of Texas Health Science Center, Memorial Hermann Hospital
  • Charleston Area Medical Center
  • University of Calgary Health Science Center : Foothills Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

hypothermia

control

Arm Description

Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours.

treated at normothermia

Outcomes

Primary Outcome Measures

The Dichotomized Glasgow Outcome Scale
The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2014
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00178711
Brief Title
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
Acronym
NABIS:HIIR
Official Title
National Acute Brain Injury Study: Hypothermia IIR
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 after injury compared to patients randomized to normothermia.
Detailed Description
NABIS:HIIR was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis was 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypothermia
Arm Type
Active Comparator
Arm Description
Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours.
Arm Title
control
Arm Type
No Intervention
Arm Description
treated at normothermia
Intervention Type
Device
Intervention Name(s)
Hypothermia
Other Intervention Name(s)
moderate hypothermia
Intervention Description
Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours
Primary Outcome Measure Information:
Title
The Dichotomized Glasgow Outcome Scale
Description
The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.
Time Frame
6 months with a window of plus or minus one month
Other Pre-specified Outcome Measures:
Title
Glasgow Outcome Scale - Extended
Time Frame
0-12 months
Title
Disability Rating Scale
Time Frame
assessed 0-12 months
Title
Neurobehavioral Rating Scale - Revised
Time Frame
0-12 months
Title
Neurological Outcome Scale for Traumatic Brain Injury
Time Frame
0-12 months
Title
Symbol Digit Modalities Test
Time Frame
0-12 months
Title
Rey Osterrieth Complex Figure
Time Frame
0-12 months
Title
Verbal Selective Reminding Test Trails B
Time Frame
0-12 months
Title
Grooved Pegboard
Time Frame
0-12 months
Title
Controlled Oral Word Association Test
Time Frame
0-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy L Clifton, MD
Organizational Affiliation
UTHSC-H
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of St Louis : St. Louis University Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Pittsburgh : University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Health Science Center, Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
University of Calgary Health Science Center : Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22839656
Citation
Clifton GL, Coffey CS, Fourwinds S, Zygun D, Valadka A, Smith KR Jr, Frisby ML, Bucholz RD, Wilde EA, Levin HS, Okonkwo DO. Early induction of hypothermia for evacuated intracranial hematomas: a post hoc analysis of two clinical trials. J Neurosurg. 2012 Oct;117(4):714-20. doi: 10.3171/2012.6.JNS111690. Epub 2012 Jul 27.
Results Reference
result
PubMed Identifier
21169065
Citation
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. doi: 10.1016/S1474-4422(10)70300-8. Epub 2010 Dec 17.
Results Reference
result

Learn more about this trial

Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

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