Normothermia Protocol for Traumatic Brain Injury Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Medivance, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medivance, Inc.
ClinicalTrials.gov Identifier:
NCT01354509
First received: May 12, 2011
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study

Resource links provided by NLM:


Further study details as provided by Medivance, Inc.:

Primary Outcome Measures:
  • Effectiveness of the Normothermia protocol [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Number of times patient's temp was above 37°C during this 96 hr period

  • Temperature vs ICP [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Number of times ICP > 20 in patients with ICP monitors

  • Neurologic Outcome of the 2 patient populations [ Time Frame: 1month, 3 months, 6 months ] [ Designated as safety issue: No ]
    Modified Rankin Scale at Hospital discharge, 3 months, and 6 months


Secondary Outcome Measures:
  • Mortality [ Time Frame: 5 days, 3 months, 6 months ] [ Designated as safety issue: No ]
    In-Hospital mortality, 3 - 6 month mortality


Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 12, 2011
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014