CClinicalTrials.gg
Sign In
Status unknownNCT01354509Updated May 18, 2011

Normothermia Protocol for Traumatic Brain Injury Patients

An observational study in Traumatic Brain Injury, sponsored by Medivance, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-05-18.

Sponsored by Medivance, Inc. · Observational

The sponsor has not verified this record recently (last verified May 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 85 Years
Sex
All
01

Study 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)
02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • Normothermia
  • fever control
  • Outcome study
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Medivance, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)

Groups and 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

06

What researchers measure

Primary outcomes

  1. Effectiveness of the Normothermia protocol

    Number of times patient's temp was above 37°C during this 96 hr period

    Time frame: 5 days

  2. Temperature vs ICP

    Number of times ICP \> 20 in patients with ICP monitors

    Time frame: 5 days

  3. Neurologic Outcome of the 2 patient populations

    Modified Rankin Scale at Hospital discharge, 3 months, and 6 months

    Time frame: 1month, 3 months, 6 months

Secondary outcomes

  1. Mortality

    In-Hospital mortality, 3 - 6 month mortality

    Time frame: 5 days, 3 months, 6 months

07

Study locations

1 of 1 sites recruiting
  • Mercy St John's Medical Center
    St Louis, Missouri 63141, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01354509
Lead sponsor
Medivance, Inc.
First posted
May 17, 2011
Start date
May 2011
Primary completion
May 2012 (estimated)
Completion
May 2013 (estimated)
Last update
May 18, 2011

Study contacts

Farid Sadaka, MD
Contact
farid.sadaka@mercy.net
214-251-6486
Catherine Krause, RN
Contact
krauca@mercy.net
314-251-5653
Farid Sadaka, MD
principal investigator · Mercy St John's Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Brain Injuries→

Other studies from this sponsor

Medivance, Inc.

Start the discussion