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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: July 24, 2007
Last updated: February 17, 2011
Last verified: February 2011

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.

Traumatic Brain Injury

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-Interventional F-Two Isoprostane Trial

Further study details as provided by University of Texas Southwestern Medical Center:

Estimated Enrollment: 50
Study Start Date: July 2007
Estimated Study Completion Date: December 2013

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00505908

Contact: Jane G Wigginton, M.D. 214-648-2917
Contact: Victoria S Warren, R.N. 214-648-3942

United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Jane G Wigginton, M.D.    214-648-2917   
Contact: Victoria S Warren, R.N.    214-648-9491   
Principal Investigator: Jane G Wigginton, M.D.         
Sub-Investigator: Christopher Madden, M.D.         
Sub-Investigator: Ahamed Idris, M.D.         
Sub-Investigator: Karla Saner, Ph.D.         
Sub-Investigator: Lisa Halvorson, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Jane G Wigginton, M.D. University of Texas Southwestern Medical Center
  More Information

Responsible Party: Jane Wigginton, M.D., UT Southwestern Medical Center Identifier: NCT00505908     History of Changes
Other Study ID Numbers: 052007-034
Study First Received: July 24, 2007
Last Updated: February 17, 2011

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries processed this record on June 22, 2017