Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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).

Official Title
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National Acute Brain Injury Study: Hypothermia IIR

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: Hypothermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hypothermia<br>Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours. | Device: Hypothermia<br>* Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours<br>* Other names: moderate hypothermia;|
| No Intervention: control<br>treated at normothermia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months with a window of plus or minus one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Hypothermia