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Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol

This study has been terminated.
(inability to recruit adequate numbers of subjects)
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Claudia Sue Robertson, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01013870
First received: November 13, 2009
Last updated: November 17, 2016
Last verified: November 2016
Results First Received: August 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Traumatic Brain Injury
Post-traumatic Stress Disorder
Interventions: Drug: Atorvastatin
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
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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
mTBI-atorvastatin Group 1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
mTBI-placebo Group 1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.

Participant Flow:   Overall Study
    mTBI-atorvastatin Group   mTBI-placebo Group
STARTED   28   24 
COMPLETED   27   21 
NOT COMPLETED   1   3 
Lost to Follow-up                1                3 



  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.
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Reporting Groups
  Description
mTBI-atorvastatin Group 1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
mTBI-placebo Group 1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
Total Total of all reporting groups

Baseline Measures
   mTBI-atorvastatin Group   mTBI-placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   24   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.1  (9.0)   29.9  (9.9)   29.5  (9.3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      10  35.7%      7  29.2%      17  32.7% 
Male      18  64.3%      17  70.8%      35  67.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      8  28.6%      10  41.7%      18  34.6% 
Not Hispanic or Latino      20  71.4%      14  58.3%      34  65.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      11  39.3%      7  29.2%      18  34.6% 
White      17  60.7%      16  66.7%      33  63.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   4.2%      1   1.9% 
Primary Language 
[Units: Participants]
     
English   27   21   48 
Spanish   1   3   4 
Education 
[Units: Participants]
     
1-8 years   1   1   2 
some high school   1   4   5 
high school graduate   8   8   16 
some college   12   6   18 
college graduate   4   3   7 
post-graduate   0   1   1 
vocational   2   0   2 
unknown   0   1   1 
Galveston Orientation and Amnesia Test Score [1] 
[Units: Participants]
     
=100   23   23   46 
<100   5   1   6 
[1] The GOAT assesses the duration of post-traumatic amnesia and was assessed on presentation to the hospital. It includes 10 items on recovery of orientation to person, place, and time and the maximum score is 100. (Levin, H., O'Donnell, V., and Grossman, R. [1979]. The Galveston Orientation and Amnesia Test. A practical scale to assess cognition after head injury. J Nerv Ment Dis 167[11], 675-684.). Categories used were normal (=100) or some abnormality (<100).
Glasgow Coma Scale Score [1] 
[Units: Participants]
     
15   27   23   50 
14   1   1   2 
[1] GCS was obtained in the emergency room on presentation as an assessment of neurological status. The score has 3 components: eye opening (1-4), verbal response (1-5), and motor response (1-6). The components are summed for a score that ranges from 3-15. Normal GCS is 15, less than 15 indicates some abnormality.
Head Abbreviated Injury Score [1] 
[Units: Participants]
     
 16   16   32 
 12   8   20 
[1] The head component of the Abbreviated Injury Score describes the severity of a head injury. The score ranges from 1-6, with a higher score indicating a more severe injury. Patients were excluded from this study if any component AIS was greater than 2.
Injury Severity Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.6  (2.0)   3.5  (1.9)   3.6  (1.9) 
[1] ISS is a score that describes the overall injury severity and was determined at presentation to the hospital. There are 9 body regions where the injury severity is assessed on a scale from 1-6, with a higher score indicating a more severe injury. Is all body region scores are < 6, then the ISS is calculated by summing the square of the 3 highest region scores. If any of the body region scores is 6 (unsurvivable) then the ISS is set to 75. The ISS score ranges from 1-75.


  Outcome Measures
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1.  Primary:   Rivermead Post-Concussion Symptoms Questionnaire, at 3 Months After Injury.   [ Time Frame: 3 months after injury ]

2.  Secondary:   Medical Outcome Study Short Form 12 - Mental Score   [ Time Frame: 3 months ]

3.  Secondary:   Medical Outcome Study Short Form 12 - Physical Score   [ Time Frame: 3 months after injury ]

4.  Secondary:   Post-traumatic Stress Checklist - Civilian Form   [ Time Frame: 3 months after injury ]

5.  Secondary:   Connor Davidson Resilience Measure   [ Time Frame: 3 months after injury ]

6.  Secondary:   Center for Epidemiological Study Depression Scale   [ Time Frame: 3 months after injury ]

7.  Secondary:   Brief Visuospatial Memory Test - Revised   [ Time Frame: 3 months after injury ]

8.  Secondary:   Symbol Digit Modalities Test - Oral Score   [ Time Frame: 3 months after injury ]

9.  Secondary:   Symbol Digit Modalities Test - Written Score   [ Time Frame: 3 months after injury ]


  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
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  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: Claudia Robertson, MD
Organization: Baylor College of Medicine
phone: 713-873-2792
e-mail: claudiar@bcm.edu


Publications:
Ware JE Jr., Kosinski M, Turner-Bowker DM, Gandek B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002
Weathers F, Litz B, Herman D, Huska J, Keane T. The PTSD Checklist [PCL]: Reliability, Validity, and Diagnostic Utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX., October 1993
Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. App Psychol Meas. 1977;1:385-401.


Responsible Party: Claudia Sue Robertson, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01013870     History of Changes
Other Study ID Numbers: W81XWH-08-2-0132
Study First Received: November 13, 2009
Results First Received: August 3, 2016
Last Updated: November 17, 2016
Health Authority: United States: Institutional Review Board