Traumatic Brain InjuryNIFTINCT00505908
Non-Interventional F-Two Isoprostane Trial (NIFTI)
An observational study of Traumatic Brain Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do "survive" do not fully recover and are… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who meet inclusion criteria and have experienced a trauamtic head injury.
Who may be able to join
- Estimated age of 18 - 50 years
- Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation.
- Systolic blood pressure of >90 mm Hg
- Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center in Dallas, Texas
Who cannot join
- Those in whom the time of injury is unknown
- Those with any 2 readings of systolic blood pressure of <90 prior to enrollment
- Those who are known to have legal Do Not Resuscitate (DNR) orders in place prior to enrollment.
- Those receiving CPR prior to enrollment
- Known incarcerated individuals
- Pulse ox reading of < 90 prior to enrollment
- Status epilepticus prior to enrollment
- Penetrating head trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Interventional F-Two Isoprostane Trial
Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do "survive" do not fully recover and are left with a varying degree of permanent disability. It is therefore imperative that new methods of early interventions be explored.
One possible road to effective therapy is to examine the timing of secondary injury via a biological marker, to help guide the timing of treatment directed specifically at early oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention, possibly peaking within the first two hours after the initial injury.
Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood, urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected over the first 5 days post-injury. Clinically-relevant patient progress, clinically required interventions, neuro-imaging results, and demographics will be tracked while the patient is hospitalized, with final neurological outcome measured at 3 months.
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of oxidant injury in cerebrospinal fluid following severe traumatic brain injury
F2 Isoprostane levels in cerebrospinal fluid following severe traumatic brain injury
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2019
- Study completionDec 2019
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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wigginton, University of Texas Southwestern Medical Center
- Investigators
- Jane G Wigginton, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505908
- Sponsor's protocol ID
- 052007-034
- Acronym
- NIFTI
- Status last verified
- Mar 2020
- First submitted
- 24 Jul 2007
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional F-Two Isoprostane Trial
- ClinicalTrials.gov ID
- NCT00505908
- Acronym / sponsor ID
- NIFTI / 052007-034
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Jul 2007 (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.
Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do "survive" do not fully recover and are left with a varying degree of permanent disability. It is therefore imperative that new methods of early interventions be explored.
One possible road to effective therapy is to examine the timing of secondary injury via a biological marker, to help guide the timing of treatment directed specifically at early oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention, possibly peaking within the first two hours after the initial injury.
Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood, urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected over the first 5 days post-injury. Clinically-relevant patient progress, clinically required interventions, neuro-imaging results, and demographics will be tracked while the patient is hospitalized, with final neurological outcome measured at 3 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who meet inclusion criteria and have experienced a trauamtic head injury.
Key inclusion criteria (4 listed)
- Estimated age of 18 - 50 years
- Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation.
- Systolic blood pressure of >90 mm Hg
- Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center in Dallas, Texas
Key exclusion criteria (8 listed)
- Those in whom the time of injury is unknown
- Those with any 2 readings of systolic blood pressure of <90 prior to enrollment
- Those who are known to have legal Do Not Resuscitate (DNR) orders in place prior to enrollment.
- Those receiving CPR prior to enrollment
- Known incarcerated individuals
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
Levels of oxidant injury in cerebrospinal fluid following severe traumatic brain injury
Time frame: Up to 5 days
F2 Isoprostane levels in cerebrospinal fluid following severe traumatic brain injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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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.
Jane G Wigginton, M.D. principal investigator
University of Texas Southwestern 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 University of Texas Southwestern Medical Center 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 16 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of oxidant injury in cerebrospinal fluid following severe traumatic brain injury (time frame: Up to 5 days). 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 16 Mar 2020.