Abdominal Aortic AneurysmNCT00416000
Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm
An observational study of Abdominal Aortic Aneurysm, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those undergoing AAA repair for elevtive and ruptured AAA by both EVAR and open methods.
Who may be able to join
- Open/Elective EVAR patients
Who cannot join
- Patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Open/Elective EVAR patients
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Secondary outcomes (1)
multiple organ failure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Thomas Lindsay, University Health Network, Toronto
- Investigators
- Thomas F Lindsay, MD, Principal investigator, TGH, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416000
- Sponsor's protocol ID
- 06-0671B
- Status last verified
- May 2014
- First submitted
- 22 Dec 2006
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00416000
- Acronym / sponsor ID
- 06-0671B
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Open/Elective EVAR patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Jan 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those undergoing AAA repair for elevtive and ruptured AAA by both EVAR and open methods.
Key inclusion criteria (1 listed)
- Open/Elective EVAR patients
Key exclusion criteria (1 listed)
- Patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
1 secondary outcome
multiple organ failure
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas F Lindsay, MD principal investigator
TGH, UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.