Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

Exclusion Criteria

• •1. No documented TBI or time of impact not certain
• •2. Penetrating brain injury
• •3. Spinal column instability and/or spinal cord injury with neurodeficit
• •4. Concomitant severe non survivable injury
• •5. Pregnant, or a positive pregnancy test
• •6. Women who intend to breastfeed during Study Days 1-4.
• •7. Blood glucose \<50mg/dL
• •8. Severe renal disorder from the patient's history (e.g. dialysis) or serum creatinine of \> 2.5 mg/dL
• •9. Severe liver disease or total bilirubin \>1.5 times upper limit of normal
• •10. INR\>1.4
• •11. Systolic BP\<90 mm Hg not responsive to fluid resuscitation
• •12. Blood alcohol \> 250mg/dL
• •13. Inability to have MRI (pacemaker, non-MR compatible pressure monitor, etc.)
• •14. Hospitalization for brain injury, psychiatric or neurological disease within previous 3 years
• •15. Emergent or urgent surgical operation anticipated (in OR, bedside procedures excluded) that would prevent dosing with study drug within 8 hours of injury.
• •16. Known use of Coumadin (warfarin), Plavix (clopidogrel), Effient (prasugrel) or Pletal (cilostazol), heparin, low molecular weight heparin, heparinoids, or abciximab or similar antiplatelet agents in the previous 72 hours (Note that patients later found to have taken these medications will not be automatically excluded from the study.)
• •17. Use of sulfonylurea drugs within the prior 30 days
• •18. Treatment with another investigational drug within the prior 30 days
• •19. Allergy to sulfonylurea drugs
• •20. Known diagnosis of G6PD enzyme deficiency
• •21. PaO2 \< 60 mm Hg on admission (for patients in whom blood gases are drawn per standard of care)
• •22. Non-English speaking legally authorized representative and subjects (University of Maryland only)
• •23. Prisoners or others who may be unable to make a truly voluntary and uncoerced decision whether or not to participate in the study
• •24. Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study