Progesterone Treatment of Blunt Traumatic Brain Injury

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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

Key facts

Study ID

NCT00048646

Run by

David Wright

People needed

100

Starts

2002-05-01

Expected to finish

2005-09-01

Last updated by the study team

2014-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Blunt head trauma occuring within 11 hours
• Ages 18 years and older (or Tanner Score of 5)
• Index GCS between 4 and 12

You may not qualify if…

• 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

Where it is running

• Emory University School of Medicine - Dept. of Emergency Medicine — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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