Brain Injuries, TraumaticNCT00522496
Proteomics of Severe Traumatic Brain Injury: A Feasibility Study
An observational study of Brain Injuries, Traumatic, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to Foothills Medical Centre, the regional trauma centre for Southern Alberta
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
David A Zygun, MD, 403-944-1691, dzygun@ucalgary.ca
David A Zygun, MD
About this study
The purpose of this study is to:
- Determine the temporal course of matrix metalloproteinase (MMP) expression in patients wiht severe traumatic brain injury
- Determine the temporal course of the expression of MMP-related inflammatory mediators of secondary injury in patients with severe traumatic brain injury
- Describe the association of physiological changes and standard microdialysis analyte measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and neuroinflammatory marker concentrations.
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Craniocerebral trauma, matrix metalloproteinase, microdialysis
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startJul 2007
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Intensive Care Foundation
- Investigators
- Zygun A David, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522496
- Sponsor's protocol ID
- 20216
- Status last verified
- Feb 2009
- First submitted
- 27 Aug 2007
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics of Severe Traumatic Brain Injury: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00522496
- Acronym / sponsor ID
- 20216
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Craniocerebral trauma, matrix metalloproteinase, microdialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Intensive Care Foundation
- Study start
- Jul 2007
- Study completion
- Aug 2009 (estimated)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
- Determine the temporal course of matrix metalloproteinase (MMP) expression in patients wiht severe traumatic brain injury
- Determine the temporal course of the expression of MMP-related inflammatory mediators of secondary injury in patients with severe traumatic brain injury
- Describe the association of physiological changes and standard microdialysis analyte measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and neuroinflammatory marker concentrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to Foothills Medical Centre, the regional trauma centre for Southern Alberta
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
Related trials for Brain Injuries, Traumatic
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zygun A David, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David A Zygun, MD (403-944-1691, dzygun@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2009.