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

The University of Texas System (UT)

Status and phase: Terminated; Phase 3

Conditions: Traumatic Brain Injury

Treatments: Device: Hypothermia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00178711

FDA-2014-109 (Other Identifier)

5U01NS043353-06

Details and patient eligibility

About

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.

Full 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).

Enrollment: 232 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups

hypothermia

Active Comparator group

Description:

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

Treatment:

Device: Hypothermia

control

No Intervention group

Description:

treated at normothermia