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

This study has been terminated.
(futility: low conditional power to demonstrate benefit of progesterone)
Sponsor:
Collaborators:
Medical University of South Carolina
Neurological Emergencies Treatment Trials Network (NETT)
Information provided by (Responsible Party):
David Wright, Emory University
ClinicalTrials.gov Identifier:
NCT00822900
First received: January 14, 2009
Last updated: December 16, 2015
Last verified: December 2015
Results First Received: April 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Traumatic Brain Injury
Interventions: Drug: Progesterone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 882 patients underwent randomization at 49 trauma centers in the United States between April 5, 2010, and October 30, 2013. 442 patients were randomized to Progesterone Arm and 440 were randomized to Placebo Arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Progesterone No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Progesterone   Placebo
STARTED   442   440 
COMPLETED   334   347 
NOT COMPLETED   108   93 
Withdrawal by Subject                14                14 
Lost to Follow-up                9                9 
Death                83                69 
Became a ward of the state                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Progesterone No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Progesterone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 442   440   882 
Age 
[Units: Years]
Mean (Standard Deviation)
 39  (18)   38  (17)   39  (18) 
Gender 
[Units: Participants]
     
Female   118   114   232 
Male   324   326   650 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   61   64   125 
Not Hispanic or Latino   347   343   690 
Unknown or Not Reported   34   33   67 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   5   2   7 
Asian   20   22   42 
Native Hawaiian or Other Pacific Islander   1   2   3 
Black or African American   70   64   134 
White   330   331   661 
More than one race   3   6   9 
Unknown or Not Reported   13   13   26 
Region of Enrollment 
[Units: Participants]
     
United States   442   440   882 
Index GCS score at randomization [1] 
[Units: Participants]
     
Moderate   129   125   254 
Moderate to severe   234   238   472 
Severe   79   77   156 
[1] The index Glasgow Coma Scale (GCS) score is the highest reliable GCS score documented before randomization.The GCS is scored between 3 and 15, 3 being the worst, and 15 the best. A score of 13 or higher correlates with a mild brain injury, 9 to 12 is a moderate injury and 8 or less a severe brain injury.


  Outcome Measures
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1.  Primary:   Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)   [ Time Frame: 6 months post randomization ]

2.  Secondary:   Mortality   [ Time Frame: 6 months ]

3.  Secondary:   Disability Rating Scale   [ Time Frame: 6 months ]

4.  Secondary:   Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis   [ Time Frame: within 6 months ]

5.  Secondary:   Potentially Associated Adverse Events: Pulmonary Embolism   [ Time Frame: within 6 months ]

6.  Secondary:   Potentially Associated Adverse Events: Acute Ischemic Stroke   [ Time Frame: within 6 months ]

7.  Secondary:   Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)   [ Time Frame: within 6 months ]

8.  Secondary:   Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level   [ Time Frame: within 6 months ]

9.  Secondary:   Potentially Associated Adverse Events: Sepsis   [ Time Frame: within 6 months ]

10.  Secondary:   Potentially Associated Adverse Events: Pneumonia   [ Time Frame: within 6 months ]

11.  Secondary:   Potentially Associated Adverse Events: Central Nervous System (CNS) Infection   [ Time Frame: within 6 months ]

12.  Secondary:   Potentially Associated Adverse Events: Myocardial Infarction (MI)   [ Time Frame: within 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial was stopped early for futility with respect to the primary outcome.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David W. Wright, Associate Professor, Department of Emergency Medicine, Emory University
Organization: Emergency Neurosciences, Emergency Medicine, Emory University
phone: 404-778-1709
e-mail: david.wright@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David Wright, Emory University
ClinicalTrials.gov Identifier: NCT00822900     History of Changes
Other Study ID Numbers: IRB00014409
1RO1 NS062778-01
Study First Received: January 14, 2009
Results First Received: April 1, 2015
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration