The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.


Title: Progesterone Treatment of Blunt Traumatic Brain Injury Principal Investigator(s): Arthur Kellermann, M.D., M.P.H. Institution: Emory University Biostatistician: Vicki Hertzberg, Ph.D. Institution: Emory University Project phase or primary methodology: Phase II pilot, double blind, 4:1 randomized controlled, clinical trial Target disease: Blunt traumatic brain injury Intervention: Intravenous progesterone infused over three days Number of patients to be enrolled: 100 Number of clinical centers: One (Grady Memorial Hospital) Primary Hypothesis: Dose: Intravenous infusion of progesterone at a dose of 0.5 mg/kg/hr produces a steady state of 450 +/- 100 nmol/L in male and female subjects. Safety: Compared to study subjects who receive placebo, subjects who receive IV progesterone do not have an increased risk of mortality or an increased incidence of adverse effects. Efficacy: Administering IV progesterone shortly following TBI produces any or all of the following effects, including: - Reduction of the intracranial pressure therapeutic intensity level (ICP-TIL). - Decreased duration of coma. - Decreased inpatient mortality. - Improved neurological outcome one month post-injury. Secondary Hypotheses: Benefit: The benefits of IV progesterone for TBI are evident across a range of clinically relevant treatment subgroups, regardless of: - Time from injury to drug administration: (i.e., 18; blunt traumatic brain injury; moderate to severe brain injury (iGCS 4-12); arrival

Eligibility Criteria:

Inclusion Criteria: - Blunt head trauma occuring within 11 hours - Ages 18 years and older (or Tanner Score of 5) - Index GCS between 4 and 12 Exclusion Criteria: - Spinal cord injury - Penetrating head trauma - Cardiopulmonary arrest upon ECC arrival - Status Epilepticus upon ECC arrival - Systolic BP 250 mg/dl - Non-English speakers (a Spanish version of the ICF is currently being developed) - Allergy(s) to soy, egg, or progesterone - Active breast or reproductive organ cancer(s) - Previous head injury or stroke within the past 6 weeks

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