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Proteomics of Severe Traumatic Brain Injury: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT00522496
Recruitment Status : Unknown
Verified February 2009 by University of Calgary.
Recruitment status was:  Recruiting
First Posted : August 29, 2007
Last Update Posted : February 24, 2009
Sponsor:
Collaborator:
Canadian Intensive Care Foundation
Information provided by:
University of Calgary

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The purpose of this study is to:

  1. Determine the temporal course of matrix metalloproteinase (MMP) expression in patients wiht severe traumatic brain injury
  2. Determine the temporal course of the expression of MMP-related inflammatory mediators of secondary injury in patients with severe traumatic brain injury
  3. Describe the association of physiological changes and standard microdialysis analyte measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and neuroinflammatory marker concentrations.

Condition or disease
Brain Injuries, Traumatic

Study Design
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Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proteomics of Severe Traumatic Brain Injury: A Feasibility Study
Study Start Date : July 2007
Estimated Study Completion Date : August 2009

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients referred to Foothills Medical Centre, the regional trauma centre for Southern Alberta
Criteria

Inclusion Criteria:

  • Patient is 18 years of age or older
  • Patient has GCS less than 9
  • Patient requires intracranial pressure monitoring
  • Patient life expectancy greater than 72 hours

Exclusion Criteria:

  • Patient's TBI is greater than 24 hours old
  • Patient is less than 18 years of age
  • Patient does not require intracranial pressure monitoring
  • Patient has life expectancy less than 72 hours
  • Patient has GCS greater or equal to 9
  • Patient is currently enrolled in another study
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522496


Contacts
Contact: David A Zygun, MD 403-944-1691 dzygun@ucalgary.ca

Locations
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: David A Zygun, MD    403-944-1691    dzygun@ucalgary.ca   
Principal Investigator: David A Zygun, MD         
Sub-Investigator: John Hurlbert, MD         
Sub-Investigator: Ian Parney, MD         
Sub-Investigator: Walter Hader, MD         
Sub-Investigator: Clare Gallagher, MD         
Sub-Investigator: Wee Yong, P.hD         
Sub-Investigator: Christopher Doig, MD         
Sub-Investigator: Paul Kubes, MD         
Sub-Investigator: Andreas Kramer, MD         
Sponsors and Collaborators
University of Calgary
Canadian Intensive Care Foundation
Investigators
Principal Investigator: Zygun A David, MD University of Calgary
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: David Zygun Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT00522496     History of Changes
Other Study ID Numbers: 20216
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

Keywords provided by University of Calgary:
Craniocerebral trauma
matrix metalloproteinase
microdialysis

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System