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

This study has been terminated.
(Futility)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Guy Clifton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178711
First received: September 13, 2005
Last updated: September 13, 2014
Last verified: September 2014

September 13, 2005
September 13, 2014
November 2005
December 2009   (final data collection date for primary outcome measure)
The Dichotomized Glasgow Outcome Scale [ Time Frame: 6 months with a window of plus or minus one month ] [ Designated as safety issue: No ]
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.
The primary outcome measure for the 48-hour moderate hypothermia protocol will be the dichotomized Glasgow Outcome Scale measured by blinded assessment of patients at six months post-injury.
Complete list of historical versions of study NCT00178711 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Glasgow Outcome Scale - Extended [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Disability Rating Scale [ Time Frame: assessed 0-12 months ] [ Designated as safety issue: No ]
  • Neurobehavioral Rating Scale - Revised [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Neurological Outcome Scale for Traumatic Brain Injury [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Symbol Digit Modalities Test [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Rey Osterrieth Complex Figure [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Verbal Selective Reminding Test Trails B [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Grooved Pegboard [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Controlled Oral Word Association Test [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
Not Provided
 
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
National Acute Brain Injury Study: Hypothermia IIR

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
Device: Hypothermia
Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours
Other Name: moderate hypothermia
  • Active Comparator: hypothermia
    Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours.
    Intervention: Device: Hypothermia
  • No Intervention: control
    treated at normothermia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
232
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. GCS = 3 AND bilaterally non-reactive pupils
  3. Abbreviated Injury Score (AIS) > 4 for any body area except head
  4. Positive abdominal ultrasound or CT scan
  5. Persistent hypotension (systolic blood pressure < 110mmHGg)
  6. Persistent hypoxia (O2 Saturation < 94%)
  7. Positive pregnancy test
  8. Injured greater than 2.5 hours from hospital arrival
  9. Pre-existing medical conditions, if known
Both
16 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00178711
5U01 NS043353-06, FDA-2014-109
Yes
Guy Clifton, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Guy L Clifton, MD UTHSC-H
The University of Texas Health Science Center, Houston
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP