Normothermia Protocol for Traumatic Brain Injury Patients

NCT01354509 | Unknown DMC

• 1 other identifier: MDV_STL_001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)

1. 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. 2.Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)

Conditions

Traumatic Brain Injury

Keywords

Normothermia; fever control; Outcome study

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Mortality

  5 days, 3 months, 6 months

Study Arms (2)

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 Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Medivance, Inc.: lead

Study Sites (1)

Mercy St John's Medical Center

St Louis, Missouri, 63141, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Farid Sadaka, MD

  Mercy St John's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farid Sadaka, MD

CONTACT

214-251-6486; farid.sadaka@mercy.net

Catherine Krause, RN

CONTACT

314-251-5653; krauca@mercy.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 17, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 18, 2011

Record last verified: 2011-05

Locations

US (1)