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Transforming Research and Clinical Knowledge in TBI Pilot

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01565551
First received: March 24, 2012
Last updated: January 3, 2014
Last verified: January 2014
Results First Received: January 3, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Traumatic Brain Injury
Intervention: Other: N/A (Observational Study)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Early-Presenting TBI: Acute Sites

This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).

N/A (Observational Study): No Interventions: Observational Study

Late-Presenting TBI: Rehabilitation Center

This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).

N/A (Observational Study): No Interventions: Observational Study


Participant Flow:   Overall Study
    Early-Presenting TBI: Acute Sites   Late-Presenting TBI: Rehabilitation Center
STARTED   586   51 
Clinical/Demographics   586   51 
Biospecimens/Biomarkers   479   22 
Neuroimaging   233   25 
6-Month Outcomes   412   30 
COMPLETED   586   51 
NOT COMPLETED   0   0 



  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
Early-Presenting TBI: Acute Sites

This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).

N/A (Observational Study): No Interventions: Observational Study

Late-Presenting TBI: Rehabilitation Center

This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).

N/A (Observational Study): No Interventions: Observational Study

Total Total of all reporting groups

Baseline Measures
   Early-Presenting TBI: Acute Sites   Late-Presenting TBI: Rehabilitation Center   Total 
Overall Participants Analyzed 
[Units: Participants]
 586   51   637 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.3  (18.5)   49.9  (20.4)   43.9  (18.7) 
Gender 
[Units: Participants]
     
Female   167   14   181 
Male   419   37   456 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   3   0   3 
Asian   22   2   24 
Native Hawaiian or Other Pacific Islander   17   0   17 
Black or African American   46   9   55 
White   471   39   510 
More than one race   21   0   21 
Unknown or Not Reported   6   1   7 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   84   5   89 
Not Hispanic or Latino   495   33   528 
Unknown or Not Reported   7   13   20 


  Outcome Measures

1.  Primary:   Glasgow Outcome Scale Extended (GOSE)   [ Time Frame: 6 Months Post-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
Enrolling patients representative of the TBI population created challenges for follow-up (e.g. homelessness, substance abuse); limited access to research MRI scanner; lack of validated outcome measures for non-English-speaking and pediatric patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Geoffrey Manley, MD, PhD
Organization: University of California, San Francisco
phone: 415-206-8300
e-mail: manleyg@neurosurg.ucsf.edu


Publications:
Finkelstein E, Corso P, Miller T. The Incidence and Economic Burden of Injuries in the United States. New York, NY: Oxford University Press; 2006.
Foulkes AM, Eisenberg MH, Jane AJ. The Traumatic Coma Data Bank; design, methods and baseline characteristics. J. Neuroch. 75, S1-S15, 1991
Ng J, Wahl M, Tong L, Lee H, Veeraraghavan S, Xu D, Zhao S, Kornak J, Meeker M, Ghajar J, Manley GT, Mukherjee P. 3T Diffusion Tensor Imaging of Mild Traumatic Brain Injury: A Prospective Longitudinal Study. Proc ISMRM 2009; 641.

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


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01565551     History of Changes
Other Study ID Numbers: RC2NS069409 ( US NIH Grant/Contract Award Number )
Study First Received: March 24, 2012
Results First Received: January 3, 2014
Last Updated: January 3, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board