Proteomics of Severe Traumatic Brain Injury: A Feasibilit... | NCT00522496

Studies
Proteomics of Severe Traumatic Brain Injury: A Feasibility Study

NCT00522496

Sponsor

University of Calgary

Status

Unknown status

Last Update Posted

Feb 24, 2009Estimated

Enrollment

8Estimated

Phase

Not provided

Conditions

Brain Injuries, Traumatic

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Aug 2009Estimated

First Submitted Date

Aug 27, 2007

First Submission Date that Met QC Criteria

Aug 27, 2007

First Posted Date

Aug 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2009

Last Update Posted Date

Feb 24, 2009Estimated

Name	Class
Canadian Intensive Care Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients referred to Foothills Medical Centre, the regional trauma centre for Southern Alberta

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David A Zygun, MD	Contact	403-944-1691		dzygun@ucalgary.ca

Overall Officials

Name	Affiliation	Role
Zygun A David, MD	University of Calgary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Foothills Medical Centre	Recruiting	Calgary	Alberta	T2N 2T9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D006259	Craniocerebral Trauma

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided