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Non-Interventional F-Two Isoprostane Trial (NIFTI)

NCT00505908 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-03-16

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Jane G Wigginton, M.D. · University of Texas Southwestern Medical Center

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505908 on ClinicalTrials.gov