Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Thomas Lindsay, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00416000
First received: December 22, 2006
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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
Abdominal Aortic Aneurysm

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • multiple organ failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 24
Study Start Date: January 2006
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Those undergoing AAA repair for elevtive and ruptured AAA by both EVAR and open methods.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416000

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Thomas Lindsay, Professor of Surgery, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00416000     History of Changes
Other Study ID Numbers: 06-0671B
Study First Received: December 22, 2006
Last Updated: May 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Open/Elective EVAR patients

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 01, 2014