Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm

Abdominal Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416000
• Other study ID #: 06-0671B
• Status: Completed
• Phase: N/A
• First received: December 22, 2006
• Last updated: May 20, 2014
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: May 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Open/Elective EVAR patients

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days	No
Secondary	multiple organ failure		30 days	No