Non-Interventional F-Two Isoprostane Trial (NIFTI)



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 50
Updated:1/13/2019
Start Date:July 2007
End Date:December 2020
Contact:Jane G Wigginton, M.D.
Email:jane.wigginton@utsouthwestern.edu
Phone:214-648-2917

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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.


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
We found this trial at
1
site
5201 Harry Hines Blvd
Dallas, Texas 75235
(214) 590-8000
Principal Investigator: Jane G Wigginton, M.D.
Phone: 214-648-2917
Parkland Memorial Hospital As our community's public health system, Parkland is the foundation for a...
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