Progesterone for Traumatic Brain Injury - Full Text View

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
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00822900

Purpose

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
Traumatic Brain Injury	Drug: Progesterone	Phase III

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Progesterone

U.S. FDA Resources

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

Further study details as provided by Emory University:

Primary Outcome Measures:

Progesterone will significantly increase the proportion of patients with a favorable outcome as determined by the Glasgow Outcome Scale-Extended (GOSE) score at 6 months post injury when compared to placebo. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Examine the efficacy of IV progesterone vs. placebo for treating patients with moderate to severe TBI on additional 6 month outcomes: Mortality, DRS, cognitive, neurological and functional outcomes, and rates of AE's and SAE's. [ Time Frame: unknown ] [ Designated as safety issue: No ]

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
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.	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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non English or Spanish speaking
Non-Survivable injury
Bilateral dilated unresponsive pupils
Severe intoxication (ETOH > 250 mg %)
Spinal cord injury with neurological deficits
Cardiopulmonary arrest
Status epilepticus on arrival
SBP < 90 on arrival or for at least 5 minutes prior to enrollment
O2 Sat < 90 on arrival or for at least 5 minutes prior to enrollment
Prisoner or ward of state
Pregnant
Active breast or reproductive organ cancers
Known allergy to progesterone or Intralipid components (egg yolk)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822900

Contacts

Contact: Harriet A Howlett-Smith, RN	404-616-6090	hhowlet@emory.edu
Contact: David W Wright, MD	404-616-6010	david.wright@emory.edu

Locations

United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303

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

More Information

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

Trauma
Brain Injury

Study placed in the following topic categories:

Craniocerebral Trauma
Progesterone
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Progestins
Physiological Effects of Drugs
Nervous System Diseases

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009