Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Emory University
Sponsor:
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
History of Changes

January 14, 2009
May 14, 2013
March 2010
June 2015   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00822900 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Progesterone for the Treatment of Traumatic Brain Injury
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.

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
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.
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.
Intervention: Drug: Progesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1140
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United States
 
NCT00822900
IRB00014409, 1RO1 NS062778-01
Yes
David Wright, Emory University
David Wright
Not Provided
Principal Investigator: David W Wright, MD Emory University
Emory University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP