Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Phase 3TerminatedNCT00178711

The University of Texas Health Science Center, Houston232 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

232

Conditions

Traumatic Brain Injury

Interventions

HypothermiaDEVICE

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (5)

University of St Louis : St. Louis University Hospital

St Louis, Missouri, United States

University of Pittsburgh : University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Texas Health Science Center, Memorial Hermann Hospital

Houston, Texas, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months with a window of plus or minus one month

Data from ClinicalTrials.gov

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