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Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00416000
Collaborator
The Physicians' Services Incorporated Foundation (Other)
24
Enrollment
1
Location
59
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients have developed complications with lung and kidney function. This study will investigate certain biochemical processes that will potentially reduce these complications. Knowledge gained from this study may also be used to further research in this field through larger studies.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Phase 1 Study of Complement Activation Following Ruptured Abdominal Aortic Aneurysm: Combining Human Observation With Animal Experimentation to Establish a Framework for Human Therapy
    Study Start Date :
    Jan 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [30 days]

    Secondary Outcome Measures

    1. multiple organ failure [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Open/Elective EVAR patients
    Exclusion Criteria:
    • Patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Toronto General Hospital Toronto Ontario Canada M5G 2C4

    Sponsors and Collaborators

    • University Health Network, Toronto
    • The Physicians' Services Incorporated Foundation

    Investigators

    • Principal Investigator: Thomas F Lindsay, MD, TGH, UHN

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Lindsay, Professor of Surgery, University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT00416000
    Other Study ID Numbers:
    • 06-0671B
    First Posted:
    Dec 27, 2006
    Last Update Posted:
    May 21, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Thomas Lindsay, Professor of Surgery, University Health Network, Toronto
    Open/Elective EVAR patients
    Additional relevant MeSH terms:
    Aneurysm
    Aortic Aneurysm
    Aortic Aneurysm, Abdominal

    Study Results

    No Results Posted as of May 21, 2014