Traumatic Brain InjuryNCT01354509
Normothermia Protocol for Traumatic Brain Injury Patients
An observational study of Traumatic Brain Injury, run by Medivance, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe TBI patients(GCS 3-9) admitted to ICU
Who may be able to join
- Severe TBI patients(GCS 3-9) admitted to ICU
Who cannot join
- Less than 18 years OLD.
- Bleeding disorders.
- Pregnancy/Breastfeeding.
- Hepatic Encephalopathy.
- Spinal cord injury (know or new)
- Fever >100 F prior to randomization.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mercy St John's Medical Center
St Louis, Missouri, 63141
Farid Sadaka, MD, 214-251-6486, farid.sadaka@mercy.net
Catherine Krause, RN, 314-251-5653, krauca@mercy.net
About this study
Official title: Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)
- 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)
- 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
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Normothermia protocol
Number of times patient's temp was above 37°C during this 96 hr period
Measured: 5 days
Temperature vs ICP
Number of times ICP > 20 in patients with ICP monitors
Measured: 5 days
Neurologic Outcome of the 2 patient populations
Modified Rankin Scale at Hospital discharge, 3 months, and 6 months
Measured: 1month, 3 months, 6 months
Secondary outcomes (1)
Mortality
In-Hospital mortality, 3 - 6 month mortality
Measured: 5 days, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medivance, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Farid Sadaka, MD, Principal investigator, Mercy St John's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354509
- Sponsor's protocol ID
- MDV_STL_001
- Status last verified
- May 2011
- First submitted
- 12 May 2011
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermia Protocol for Traumatic Brain Injury Patients: An Outcome Study
- ClinicalTrials.gov ID
- NCT01354509
- Acronym / sponsor ID
- MDV_STL_001
- Conditions
- Traumatic Brain Injury
- Keywords
- Normothermia, fever control, Outcome study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medivance, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets)
- 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)
- Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe TBI patients(GCS 3-9) admitted to ICU
Key inclusion criteria (1 listed)
- Severe TBI patients(GCS 3-9) admitted to ICU
Key exclusion criteria (11 listed)
- Less than 18 years OLD.
- Bleeding disorders.
- Pregnancy/Breastfeeding.
- Hepatic Encephalopathy.
- Spinal cord injury (know or new)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of the Normothermia protocol
Time frame: 5 days
Number of times patient's temp was above 37°C during this 96 hr period
Temperature vs ICP
Time frame: 5 days
Number of times ICP > 20 in patients with ICP monitors
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
1 secondary outcome
Mortality
Time frame: 5 days, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farid Sadaka, MD principal investigator
Mercy St John's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Medivance, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farid Sadaka, MD (214-251-6486, farid.sadaka@mercy.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the Normothermia protocol (time frame: 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.