Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III)

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.

Description:

The purpose of this trial is to determine if progesterone is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.

According to the Centers for Disease Control and Prevention, approximately 1.5 to 2 million adults and children in the United States suffering from traumatic brain injuries each year, leading to 50,000 deaths and 80,000 new cases of long-term disability.

Progesterone is a protection hormone naturally present in small but measurable amounts in the human brain.  In an earlier study, researchers found that progesterone given to trauma victims shortly after brain injury appears to be safe and may reduce the risk of death and long-term disability.  They hope to confirm these preliminary findings and determine if progesterone benefits victims of acute traumatic brain injury.

This multicenter, randomized, double-blinded study will enroll 1140 participants at multiple hospitals across the US.  In this study, researchers will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours) along with standard medical care for brain injury is more effective at limiting the amount of damage caused by a traumatic brain injury than standard medical care alone.

Phase: 

Eligibility Criteria:

Inclusion:

• Moderate to severe brain injury (Glasgow Coma Scale 12-4)
• Age 18 years or older
• Blunt, closed head injury
• Arrival < 4 hours from injury

Exclusion:

• Bilateral dilated unresponsive pupils
• Severe intoxication (ethanol > 250 mg %)
• Spinal cord injury with neurological deficits
• Inability to perform activities of daily living prior to injury
• Cardiopulmonary arrest
• Status epilepticus on arrival
• Systolic blood pressure < 90 on arrival or for at least 5 minutes prior to enrollment
• Oxygen saturation < 90 on arrival or for at least 5 minutes prior to enrollment
• Pregnant
• Active breast or reproductive organ cancers
• Known allergy to progesterone or intralipid components (egg yolk)
• Known history of clotting disorder
• Active thromboembolic event
• Concern for inability to follow up at 6 months

Study Design: 

Study Locations: 

For more information:

Contact:  David W Wright, MD 404-778-1709 david.wright@emory.edu; or Rie Calcaterra, 404-778-1713 acalc01@emory.edu

Visit:  http://clinicaltrials.gov/ct2/show/NCT00822900

Last Reviewed November 9, 2012