Normothermia Protocol for Traumatic Brain Injury Patients

Status unconfirmed

Conditions studied: Traumatic Brain Injury

In brief

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)

Key facts

Study ID

NCT01354509

Run by

Medivance, Inc.

People needed

80

Starts

2011-05-01

Expected to finish

2013-05-01

Last updated by the study team

2011-05-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe TBI patients(GCS 3-9) admitted to ICU

You may not qualify if…

• 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.

Where it is running

• Mercy St John's Medical Center — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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