Normothermia Protocol for Traumatic Brain Injury Patients

Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study

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)

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • Mercy St John's Medical Center
      • Contact: Farid Sadaka, MD; Phone Number: 214-251-6486; Email: farid.sadaka@mercy.net
      • Contact: Catherine Krause, RN; Phone Number: 314-251-5653; Email: krauca@mercy.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the Normothermia protocol	Number of times patient's temp was above 37°C during this 96 hr period	5 days
Temperature vs ICP	Number of times ICP > 20 in patients with ICP monitors	5 days
Neurologic Outcome of the 2 patient populations	Modified Rankin Scale at Hospital discharge, 3 months, and 6 months	1month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	In-Hospital mortality, 3 - 6 month mortality	5 days, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Medivance, Inc.
• Investigators: Principal Investigator: Farid Sadaka, MD, Mercy St John's Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): May 1, 2012
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Estimate): May 18, 2011
• Last Update Submitted That Met QC Criteria: May 17, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Normothermia; fever control; Outcome study
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: MDV_STL_001