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: June 24, 2015
Last verified: June 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
Intervention: Drug: Progesterone

  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  
Number of Participants  
[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


No publications provided by Emory University

Publications automatically indexed to this study:

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: June 24, 2015
Health Authority: United States: Food and Drug Administration