Traumatic Brain Injury
Conditions
Keywords
Normothermia, fever control, Outcome study
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)
Interventions
None listed
Sponsors
Medivance, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurologic Outcome of the 2 patient populations | 1month, 3 months, 6 months | Modified Rankin Scale at Hospital discharge, 3 months, and 6 months |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 5 days, 3 months, 6 months | In-Hospital mortality, 3 - 6 month mortality |
Countries
United States
Contacts
Primary ContactFarid Sadaka, MD
Backup ContactCatherine Krause, RN
Outcome results
None listed