NCT01327820

Brief Summary

To define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

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

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

March 31, 2011

Last Update Submit

March 23, 2016

Conditions

Oxygen ConsumptionAortic AneurysmPeripheral Arterial Disease

Keywords

Oxygen consumptionAortic AneurysmPeripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Whole body oxygen consumption

    post-operative day 1

Study Arms (3)

Open aortic aneurysm repair

Endovascular aortic aneurysm repair

Infra-inguinal lower limb revascularisation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh

You may qualify if:

  • Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Aortic AneurysmPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 4, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 24, 2016

Record last verified: 2011-03

Locations

GB(1)