Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Phase 3

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Device: Hypothermia

• Registration Number: NCT00178711
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Study Start: 2005-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2014-07-31
• Results First Submitted QC: 2014-08-08
• Results First Posted: 2014-08-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-13
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The Dichotomized Glasgow Outcome Scale	6 months with a window of plus or minus one month	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.

Trial Locations

Locations (5)

University of Calgary Health Science Center : Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

University of St Louis : St. Louis University Hospital; 🇺🇸 St. Louis, Missouri, United States

Charleston Area Medical Center; 🇺🇸 Charleston, West Virginia, United States

University of Texas Health Science Center, Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

University of Pittsburgh : University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States