Medical Student Research Fellowship for Summer 2007

Mentor: Jane G. Wigginton, MD
Department: Surgery; Dallas/Fort Worth Center for Resuscitation Research, Division of Resuscitative Endocrinology
Room Number: E7.202
Mail Code: 9031
Phone Number: 8-9491
E-mail: Jane.Wigginton@UTSouthwestern.edu
Project Title: NIFTI-TBI Trial, RESCUE - TBI Trial

Human Subjects IRB approved project number (where applicable):
Animal Subjects IRB approved project number (where applicable):

Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects): Patient-based research

Brief Description of the NIFTI-TBI (Non-Interventional F-Two Isoprostane- Traumatic Brain Injury) Trial:

Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. The average age of these patients is 30. 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. A significant cause of this mortality and persistent morbidity may be due to potentially preventable secondary injury, namely oxidant injury and subsequent apoptosis in the penumbra, occurring in the first few hours after the severe traumatic event. One possible road to significantly improve therapy for these patients is to characterize the timing of this oxidant injury via a marker. F2-isoprostane is a proven marker of oxidant injury, yet has never been examined in an early, serial manner in this patient population until now, through our NIFTI - TBI study. These F2-isoprostane levels may now be poised to better direct our care, guiding us to begin therapy against this oxidant injury very early after the initial injury.

This ground breaking NIFTI - TBI study is being conducted to serially examine the levels of specific biomarkers present in both Cerebrospinal Fluid (CSF) and blood, the results of which should provide the following firsts:
1) Elucidate the peak timing of early oxidant injury, which will directly impact the timing of interventions for these patients
2) Identity the amount of oxidant injury seen in the three different types of TBI, which may guide the specific therapies used for these patients
3) Identify any subsequent peaks in oxidant injury, which, if identified, will lead to further improvements in patient care
4) Identify any correlations between CSF and serum levels of F2-isoprostane, which may help guide therapy for less severely TBI patients not requiring a ventriculostomy
5) Identify correlations of marker levels with patients' progress, and need for critical interventions, which may alert physicians to problems requiring intervention before they would be otherwise clinically evident

Brief Description of RESCUE - TBI (Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Brain Injury)Trial

Epidemiologic studies have shown women generally survive traumatic injury, sudden cardiac arrest, hemorrhage and sepsis better than men. Numerous recent animal studies observing the effects of sex steroids on both sexes of injured animals have overwhelmingly found estrogen to be effective at mitigating the devastating secondary injury brought about by oxidant injury, with up to a 65% reduction in injury for multiple different injury types. Based on these important observations, the RESCUE - TBI Trial is the first clinical study to ever utilize a single dose of IV estrogen as an acute resuscitation drug. It is hoped that patients with severe TBI will have a new, safe, effective therapy in the near future, based on the results of this pilot trial.

For the NIFTI - TBI and the RESCUE - TBI Trials, the goals for the student will be to:

1. Develop an improved global understanding of human research
2. Learn techniques involving human specimen handling
3. Learn techniques involving basic laboratory tests
4. Learn techniques involving the preparation and shipping of human lab samples
5. Have direct patient contact in a critical care setting, which will afford them the opportunity to improve clinical skills.
6. Participate in the screening, enrolling and consenting of patients
7. Follow patients over time, alongside our staff research coordinators
8. Understand the importance of chart review (including collection of data, verification of diagnoses, and simple entry and analysis of data)
9. Develop skills in the areas of writing abstracts and journal articles

Both trials will allow for extensive exposure to human study participants, and will therefore require students to become certified in Human Subject Protections, and HIPAA Regulations (all training is online and simple to complete).

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