Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-12-31

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.

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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).

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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hypothermia

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

Group Type ACTIVE_COMPARATOR

Hypothermia

Intervention Type DEVICE

Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours

control

treated at normothermia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypothermia

Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours

Intervention Type DEVICE

Other Intervention Names

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moderate hypothermia

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No