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Normothermia Protocol for Traumatic Brain Injury Patients

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ClinicalTrials.gov Identifier: NCT01354509
Recruitment Status : Unknown
Verified May 2011 by Medivance, Inc..
Recruitment status was:  Recruiting
First Posted : May 17, 2011
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
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)

Condition or disease
Traumatic Brain Injury

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study
Study Start Date : May 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Current protocol group
Patients treated with current standards based on physician discretion.
Normothermia group
Normothermia protocol, using Hydrogel cooling Pads(Arctic Sun) applied for 96 hrs starting upon admission to the ICU



Primary Outcome Measures :
  1. Effectiveness of the Normothermia protocol [ Time Frame: 5 days ]
    Number of times patient's temp was above 37°C during this 96 hr period

  2. Temperature vs ICP [ Time Frame: 5 days ]
    Number of times ICP > 20 in patients with ICP monitors

  3. Neurologic Outcome of the 2 patient populations [ Time Frame: 1month, 3 months, 6 months ]
    Modified Rankin Scale at Hospital discharge, 3 months, and 6 months


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 5 days, 3 months, 6 months ]
    In-Hospital mortality, 3 - 6 month mortality



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe TBI patients(GCS 3-9) admitted to ICU
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354509


Contacts
Contact: Farid Sadaka, MD 214-251-6486 farid.sadaka@mercy.net
Contact: Catherine Krause, RN 314-251-5653 krauca@mercy.net

Locations
United States, Missouri
Mercy St John's Medical Center Recruiting
St Louis, Missouri, United States, 63141
Contact: Farid Sadaka, MD    214-251-6486    farid.sadaka@mercy.net   
Contact: Catherine Krause, RN    314-251-5653    krauca@mercy.net   
Sponsors and Collaborators
Medivance, Inc.
Investigators
Principal Investigator: Farid Sadaka, MD Mercy St John's Medical Center

Responsible Party: Farid Sadaka, MD, Mercy St John's Medical Center
ClinicalTrials.gov Identifier: NCT01354509     History of Changes
Other Study ID Numbers: MDV_STL_001
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011

Keywords provided by Medivance, Inc.:
Normothermia
fever control
Outcome study

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System