Normothermia Protocol for Traumatic Brain Injury Patients
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT01354509
- Lead Sponsor
- Medivance, Inc.
- Brief Summary
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)
1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs from admission to Neuro ICU)
2. Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Severe TBI patients(GCS 3-9) admitted to ICU
Exclusion Criteria
- Less than 18 years OLD.
- Bleeding disorders.
- Pregnancy/Breastfeeding.
- Hepatic Encephalopathy.
- Spinal cord injury (know or new)
- Fever >100 F prior to randomization.
- Blood Alcohol level >80
- Participation in other Research trial.
- Inability/unwilling to obtain Informed consent.
- Terminal illness(not expected to survive 3-6 months)
- Not expected to survive 24 hrs.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of the Normothermia protocol 5 days Number of times patient's temp was above 37°C during this 96 hr period
Temperature vs ICP 5 days Number of times ICP \> 20 in patients with ICP monitors
Neurologic Outcome of the 2 patient populations 1month, 3 months, 6 months Modified Rankin Scale at Hospital discharge, 3 months, and 6 months
- Secondary Outcome Measures
Name Time Method Mortality 5 days, 3 months, 6 months In-Hospital mortality, 3 - 6 month mortality
Trial Locations
- Locations (1)
Mercy St John's Medical Center
🇺🇸St Louis, Missouri, United States