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Non-Interventional F-Two Isoprostane Trial (NIFTI) (NIFTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505908
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : March 16, 2020
Information provided by (Responsible Party):
Wigginton, University of Texas Southwestern Medical Center

Brief 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 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.

Condition or disease
Traumatic Brain Injury

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Non-Interventional F-Two Isoprostane Trial
Study Start Date : July 2007
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who meet inclusion criteria and have experienced a trauamtic head injury.

Inclusion Criteria:

  1. Estimated age of 18 - 50 years
  2. Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation.
  3. Systolic blood pressure of >90 mm Hg
  4. Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center in Dallas, Texas

Exclusion Criteria:

  1. Those in whom the time of injury is unknown
  2. Those with any 2 readings of systolic blood pressure of <90 prior to enrollment
  3. Those who are known to have legal Do Not Resuscitate (DNR) orders in place prior to enrollment.
  4. Those receiving CPR prior to enrollment
  5. Known incarcerated individuals
  6. Pulse ox reading of < 90 prior to enrollment
  7. Status epilepticus prior to enrollment
  8. Penetrating head trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505908

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United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Jane G Wigginton, M.D. University of Texas Southwestern Medical Center
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Responsible Party: Wigginton, Associate Professor, University of Texas Southwestern Medical Center Identifier: NCT00505908    
Other Study ID Numbers: 052007-034
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries