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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2016 |
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Main ID: |
NCT01417910 |
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Date of registration:
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01/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients
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Scientific title:
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Prognostic Markers of Outcome in Patients Undergoing Infra-inguinal Revascularisation. A Prospective Observational Study. |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01417910 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Simon J Davies, MBChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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York Teaching Hospital NHS Foundation Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients undergoing elective and expedited infra inguinal peripheral
revascularisation. Patients undergoing radiological assessment (angiography) and/or
radiological intervention for peripheral vascular disease
Exclusion Criteria:
- Patients refusing to participate in the study or unable to give informed consent.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vascular Diseases
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Primary Outcome(s)
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1 year all cause mortality
[Time Frame: 1 year]
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Secondary Outcome(s)
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Medical post operative complications
[Time Frame: participants will be followed for the duration of hospital stay, an expected median of 10 days]
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Surgical post operative complications
[Time Frame: participants will be followed for the duration of hospital stay, an expected median of 10 days]
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Morbidity as measured by the Post operative morbidity survey
[Time Frame: 7 days]
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major adverse cardiac event.
[Time Frame: participants will be followed for the duration of hospital stay, an expected median of 10 days]
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Quality of life measured at 6 and 12 months postoperatively by the EQ-5D-5L questionnaire.
[Time Frame: 0,6 and 12 months]
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1 year major adverse cardiac event.
[Time Frame: 1 year]
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30 day all cause mortality.
[Time Frame: 30 day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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