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

Traumatic Brain Injury Clinical Trial

Official title:
National Acute Brain Injury Study: Hypothermia IIR

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00178711
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact
Status Terminated
Phase Phase 3
Start date November 2005
Completion date December 2009
View Details
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