A Study to Evaluate the Safety and Tolerability of Valproic Acid in Trauma Patients(Part 2)

Inclusion Criteria

• •1. Male and non-pregnant female trauma patients between the ages of 18-70 years, inclusive.
• •2. Blunt or penetrating trauma resulting in two or more systolic blood pressure readings of ≤ 110 mmHg at any point during transport to the hospital or within the first hour after arrival in the emergency department. Systolic blood pressure readings of ≤ 110 mmHg need not be consecutive (Eastridge et al., 2007).
• •3. Patient's admission to the emergency department results in trauma team activation (per institutional criteria, see Appendix 7).
• •4. Patient's injuries are considered potentially survivable by the attending trauma surgeon on initial evaluation.
• •5. Able to provide informed consent or consent can be obtained from a representative (spouse or other legally authorized representative) in the event that the subject is unconscious or otherwise impaired.
• •6. Female subjects must be postmenopausal, surgically sterilized, or have a negative urinary pregnancy test on arrival. Criteria for menopause include age \> 45 with absence of menses for \> 12 months. Criteria for surgical sterilization include hysterectomy and/or oophorectomy. Tubal ligation with menses within the past 12 months is not considered to be surgical sterilization.
• •7. Body mass index (BMI) between 18 kg/m2 and 35 kg/m2