Clinical trial NCT00178711: Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
Official title: National Acute Brain Injury Study: Hypothermia IIR
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Hypothermia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2005-09-15
Enrollment: 232
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The Dichotomized Glasgow Outcome Scale
timeFrame: 6 months with a window of plus or minus one month
Secondary outcomes:
Other outcomes:
measure: Glasgow Outcome Scale - Extended
timeFrame: 0-12 months
measure: Disability Rating Scale
timeFrame: assessed 0-12 months
measure: Neurobehavioral Rating Scale - Revised
timeFrame: 0-12 months
measure: Neurological Outcome Scale for Traumatic Brain Injury
timeFrame: 0-12 months
measure: Symbol Digit Modalities Test
timeFrame: 0-12 months
measure: Rey Osterrieth Complex Figure
timeFrame: 0-12 months
measure: Verbal Selective Reminding Test Trails B
timeFrame: 0-12 months
measure: Grooved Pegboard
timeFrame: 0-12 months
measure: Controlled Oral Word Association Test
timeFrame: 0-12 months
Locations:
city: St. Louis
country: United States
facility: University of St Louis : St. Louis University Hospital
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh : University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Science Center, Memorial Hermann Hospital
state: Texas
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Calgary
country: Canada
facility: University of Calgary Health Science Center : Foothills Medical Center
state: Alberta
Study officials:
affiliation: UTHSC-H
name: Guy L Clifton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.