NCT00416000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 27, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

4.4 years

First QC Date

December 22, 2006

Last Update Submit

May 20, 2014

Conditions

Abdominal Aortic Aneurysm

Keywords

Open/Elective EVAR patients

Outcome Measures

Primary Outcomes (1)

  • Mortality

    30 days

Secondary Outcomes (1)

  • multiple organ failure

    30 days

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Open/Elective EVAR patients

You may not qualify if:

  • Patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Thomas F Lindsay, MD

    TGH, UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 27, 2006

Study Start

January 1, 2006

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

CA(1)