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Sponsors and Collaborators: |
Emory University Henry Ford Hospital Medical College of Wisconsin New York Presbyterian Hospital Oregon Health and Science University Stanford University Temple University University of Arizona University of California University of Cincinnati University of Kentucky University of Maryland University of Minnesota University of Pennsylvania University of Texas Virginia Commonwealth University Wayne State University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00822900 |
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.
Condition | Intervention | Phase |
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Traumatic Brain Injury |
Drug: Progesterone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment |
Estimated Enrollment: | 1140 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | April 2014 |
Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Progesterone: Experimental
Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg for 72 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.
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Drug: Progesterone
Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg for 72 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Harriet A Howlett-Smith, RN | 404-616-6090 | hhowlet@emory.edu |
Contact: David W Wright, MD | 404-616-6010 | david.wright@emory.edu |
United States, Georgia | |
Grady Memorial Hospital | |
Atlanta, Georgia, United States, 30303 |
Responsible Party: | Emory University ( David W. Wright, MD ) |
Study ID Numbers: | IRB00014409, 1RO1 NS062778-01 |
Study First Received: | January 14, 2009 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00822900 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Trauma Brain Injury |
Craniocerebral Trauma Progesterone Hormone Antagonists Progestins Hormones, Hormone Substitutes, and Hormone Antagonists Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Brain Diseases Brain Injuries Hormones |
Craniocerebral Trauma Progesterone Nervous System Diseases Physiological Effects of Drugs Wounds and Injuries Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases |
Disorders of Environmental Origin Trauma, Nervous System Brain Diseases Hormones Pharmacologic Actions Progestins Brain Injuries |