Progesterone Treatment of Blunt Traumatic Brain Injury

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Wright
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Progesterone

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 < 90mmHG upon ECC arrival

• Pulse Ox of < 90 (or pO2 < 60)

• Prisoners or incarcerated individuals

• Past Hx of significant intercranial pathology

• Pregnant females

• Blood alcohol level > 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