Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III)
This study is currently recruiting participants.
Verified May 2013 by Emory University
Sponsor:
David Wright
Information provided by (Responsible Party):
David Wright, Emory University
ClinicalTrials.gov Identifier:
NCT00822900
First received: January 14, 2009
Last updated: May 14, 2013
Last verified: May 2013
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 3 Clinical Trial to Determine if Progesterone Along With Standard Medical Care for Brain Injury is More Effective at Limiting the Amount of Damage Cause by a Traumatic Brain Injury Than Standard Medical Care Alone. |
Resource links provided by NLM:
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: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mortality, DRS, cognitive, neurological and functional outcomes, and rates of adverse events and serious adverse events will be examined in moderate to severe traumatic brain injury patients who received either IV progesterone or placebo. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1140 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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/hr for 71 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/hr for 71 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 71 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-Survivable injury
- Bilateral dilated unresponsive pupils
- Severe intoxication (ETOH > 250 mg %)
- Spinal cord injury with neurological deficits
- Inability to perform activities of daily living prior to injury
- 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)
- Known history of clotting disorder
- Active thromboembolic event
- Concern for inability to follow up at 6 months
- Anyone listed in the Opt out registry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822900
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Contacts
| Contact: David W Wright, MD | 404-778-1709 | david.wright@emory.edu |
| Contact: Bethany F Lane, MSN, RN | 404-778-1714 | bethany.lane@emory.edu |
Hide Study LocationsLocations
| United States, Arizona | |
| Maricopa Integrated Health System | Recruiting |
| Phoenix, Arizona, United States, 85008 | |
| Contact: Starre Haney, RN 602-344-5758 Starre.Haney@mihs.org | |
| Principal Investigator: Patrick O'Neil, MD | |
| Banner Good Samaritan | Recruiting |
| Phoenix, Arizona, United States | |
| Contact: Donna Linda Livergood 480-412-4004 Donnalinda.livergood@bannerhealth.com | |
| Principal Investigator: Ara Feinstein, MD | |
| Scottsdale Healthcare | Recruiting |
| Scottsdale, Arizona, United States | |
| Contact: Lori Wood 480-882-5646 lwood@shc.org | |
| Principal Investigator: Joseph Zabramski, MD | |
| University of Arizona Medical Center | Recruiting |
| Tuscon, Arizona, United States, 85724 | |
| Contact: Ginny Stasinski, RN 520-626-5250 GStasinski@aemrc.arizona.edu | |
| Principal Investigator: Randall Friese, MD | |
| United States, California | |
| Stanford Medical Center | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Anita Visweswaran 650-721-1313 anitavis@stanford.edu | |
| Principal Investigator: James Quinn, MD | |
| Santa Clara Valley Hospital | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Anita Visweswaran 650-724-5770 anitavis@stanford.edu | |
| Principal Investigator: Roland Torres, MD | |
| San Francisco General Hospital | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Michele Meeker 415-206-3220 MeekerM@neurosurg.ucsf.edu | |
| Principal Investigator: Claude Hemphill, MD | |
| Regional Medical Center-San Jose | Recruiting |
| San Jose, California, United States | |
| Contact: Inderjit Dhokal idhokal@stanford.edu | |
| Principal Investigator: Kenneth Blumenfeld, MD | |
| United States, Georgia | |
| Grady Memorial Hospital | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Renee Cook, RN 404-778-1815 ncook@emory.edu | |
| Principal Investigator: Michael R Frankel, MD | |
| Principal Investigator: Jeffrey Salomone, MD | |
| United States, Kentucky | |
| University of Kentucky Medical Center | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Joann Short, RN 859-323-1771 joann.short@uky.edu | |
| Principal Investigator: Roger Humphries, MD | |
| United States, Maryland | |
| University of Maryland Shock Trauma | Active, not recruiting |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Anna Marie Lundell, RN 313-916-4565 ALUNDEL1@hfhs.org | |
| Principal Investigator: Joseph Miller, MD | |
| Detroit Receiving Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Valerie Mika 313-745-4350 vmika@med.wayne.edu | |
| Principal Investigator: Robert Welch, MD | |
| Sinai Grace Hospital | Recruiting |
| Detroit, Michigan, United States | |
| Contact: Valerie Mika 313-745-4350 vmika@med.wayne.edu | |
| Principal Investigator: Robert Welch, MD | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Jenny LaChance 810-262-6776 jlachan1@hurleymc.com | |
| Principal Investigator: Dominic Borgialli, MD | |
| Beaumont Royal Oak Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Megan Hausler 248-898-5197 Megan.Hausler@beaumont.edu | |
| Principal Investigator: Robert Swor, MD | |
| United States, Minnesota | |
| Hennepin County Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55414 | |
| Contact: Corey Sargent 612-624-7426 sarge022@umn.edu | |
| Principal Investigator: Gaylan Rockswold, MD | |
| North Memorial Hospital | Recruiting |
| Robbinsdale, Minnesota, United States | |
| Contact: Patti Reicks 763-520-7180 patty.reicks@northmemorial.com | |
| Principal Investigator: Eric Irwin, MD | |
| Regions Hospital | Recruiting |
| St. Paul, Minnesota, United States, 55101 | |
| Contact: Sandi Wewerka 651-254-7787 sandi.s.wewerka@healthpartners.com | |
| Principal Investigator: David Dries, MD | |
| United States, Missouri | |
| St. Johns Mercy Medical Center | Recruiting |
| St. Louis, Missouri, United States, 63141 | |
| Contact: Katie Krause 314-251-5653 krauca@mercy.net | |
| Principal Investigator: Farid Sadaka, MD | |
| United States, New York | |
| Columbia New York Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Cristina Falo, PhD 212-305-6071 maf9135@nyp.org | |
| Principal Investigator: Stephan Mayer, MD | |
| United States, Ohio | |
| University Hospital | Recruiting |
| Cincinnatti, Ohio, United States, 45267 | |
| Contact: Sara Stark, MEd 513-558-8450 starksk@ucmail.uc.edu | |
| Principal Investigator: Lori Shutter, MD | |
| United States, Oregon | |
| Oregon Health Sciences University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Lela Prewitt 503-494-1186 prewitt@ohsu.edu | |
| Principal Investigator: Craig Warden, MD | |
| United States, Pennsylvania | |
| St. Luke's Hospital | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Christy Stehly, RN 610-954-6076 stehlyc@slhn.org | |
| Principal Investigator: Marc Portner, MD | |
| Geisinger Medical Center | Recruiting |
| Danville, Pennsylvania, United States | |
| Contact: Cathy Miller 570-214-5513 cjmiller@geisinger.edu | |
| Principal Investigator: Shelly Timmons, MD | |
| Penn State Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Michael Khazalpour, RN 717-531-1707 ext 287338 mkhazalpour@hmc.psu.edu | |
| Principal Investigator: Michelle Fischer, MD | |
| Temple University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Patricia McNelis, RN 215-707-2235 Patricia.McNelis@tuhs.temple.edu | |
| Principal Investigator: Nina Gentile, MD | |
| University of Pennsylvania Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Katie Lammond 215-898-3428 lamondk@uphs.upenn.edu | |
| Principal Investigator: Jill Baren, MD | |
| Thomas Jefferson UniversityHospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Melissa Witt melissa.witt@jefferson.edu | |
| Principal Investigator: Jack Jallo, MD | |
| Hahnemann University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Romy Nocera, PhD 215-762-3839 Romy.Nocera@drexelmed.edu | |
| Principal Investigator: Mark Sacs, MD | |
| United States, Tennessee | |
| Regional Medical Center/Elvis Presley Memorial Trauma Center (The MED) | Recruiting |
| Memphis, Tennessee, United States | |
| Contact: Stephanie Panzer-Baggett 901-448-5714 spanzer@uthsc.edu | |
| Principal Investigator: Martin Croce, MD | |
| United States, Texas | |
| Austin/Brackenridge | Recruiting |
| Austin, Texas, United States, 78752 | |
| Contact: Laura LaChance, MA 512-610-0342 laura@researchhpcr.com | |
| Principal Investigator: TJ Milling, MD | |
| Memorial Hermann | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Misty Ottman, RN 713-500-7870 Misty.Ottman@uth.tmc.edu | |
| Principal Investigator: Elizabeth Jones, MD | |
| Brooke Army Medical Center | Recruiting |
| San Antonio, Texas, United States | |
| Contact: Rebecca Pitotti 210-916-1827 Rebecca.Pitotti@amedd.army.mil | |
| Principal Investigator: Randall McCafferty, MD | |
| United States, Virginia | |
| Virginia Commonwealth | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Randall Merchant, PhD 804-828-9528 rmerchan@vcu.edu | |
| Principal Investigator: Bruce Mathern, MD | |
| United States, Wisconsin | |
| Froedtert East Hospital | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Melissa Boettcher 414-805-2578 mboettcher@mcw.edu | |
| Principal Investigator: John Lynch, MD | |
Sponsors and Collaborators
David Wright
Investigators
| Principal Investigator: | David W Wright, MD | Emory University |
More Information
Additional Information:
No publications provided
| Responsible Party: | David Wright, Principal Investigator, Emory University |
| ClinicalTrials.gov Identifier: | NCT00822900 History of Changes |
| Other Study ID Numbers: | IRB00014409, 1RO1 NS062778-01 |
| Study First Received: | January 14, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Emory University:
|
Trauma Brain Injury |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
Progesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013