Non-Interventional F-Two Isoprostane Trial (NIFTI) (NIFTI)
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|ClinicalTrials.gov Identifier: NCT00505908|
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : March 16, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00505908
|United States, Texas|
|Parkland Memorial Hospital|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Jane G Wigginton, M.D.||University of Texas Southwestern Medical Center|