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ISRCTN
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ISRCTN48334791
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ClinicalTrials.gov identifier
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NCT00746122
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Public title
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Immediate management of patients with ruptured aneurysm: open versus endovascular repair
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Scientific title
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Can emergency endovascular aneurysm repair (eEVAR) reduce mortality from ruptured abdominal aortic aneurysm (AAA)?
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Acronym
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IMPROVE
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Serial number at source
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HTA 07/37/64
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Study hypothesis
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Ruptured abdominal aortic aneurysm is the bursting of the main blood vessel of the body (the aorta) in the belly, which causes death in over 85% of cases. An attempt at open surgical repair is made in less than half of those who arrive at hospital alive and of those receiving surgical repair only half will be alive at 30 days.
It is possible that application of new minimally invasive technology (endovascular aneurysm repair [EVAR]) would greatly improve the number of patients alive at 30 days. However not all patients are anatomically suitable for endovascular repair.
The principal research question is, to be addressed in a randomised clinical trial is:
Can a strategy of preferential endovascular repair of ruptured abdominal aortic aneurysm, versus the current practice of open surgical repair, significantly reduce the 30 day mortality of this condition?
More details can be found at: http://www.hta.ac.uk/1776
Protocol can be found at: http://www.hta.ac.uk/protocols/200700370064.pdf
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Lay summary
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Ethics approval
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Approval pending from the following ethics committees as of 02/12/2008:
1. Berkshire Research Ethics Committee (ref: 08/H0505/173)
2. Scotland A Research Ethics Committee (ref: 08/MRE00/90)
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Study design
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Randomised controlled multi-centre trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Abdominal aortic aneurysm
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Participants - inclusion criteria
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1. Both males and females, over the age of 50 years
2. Clinical suspicion of ruptured abdominal aortic aneurysm after review in Accident and Emergency (or other hospital unit)
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Participants - exclusion criteria
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1. Patients with known connective tissue disorders (e.g., Marfan syndrome) where endovascular repair may not be beneficial
2. Patients with known previous repair of an abdominal aortic aneurysm, because procedures either open or endovascular are likely to be very complex and there are no guidelines for anatomical restriction to repair
3. Deeply unconscious and moribund patients since the chances of recovery are minimal
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Anticipated start date
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01/04/2009
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Anticipated end date
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31/03/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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600
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Interventions
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The patients will be randomised to a strategy of EVAR if anatomically suitable (EVAR first) or to the standard emergency open surgery.
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Primary outcome measure(s)
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30 day mortality
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Secondary outcome measure(s)
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1. Mortality at 24-hour, in-hospital, and 1-year after the rupture
2. Complications and re-interventions related to ruptured AAA repair in 1 year
3. Major morbidity (stroke, myocardial infarction, renal or respiratory failure) in 1 year
4. Accuracy of clinical diagnosis of ruptured abdominal aortic aneurysm
5. Cost-effectiveness
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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1. 2009 publication in http://www.ncbi.nlm.nih.gov/pubmed/19464199
2. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20184048
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Contact name
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Prof
Janet
Powell
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Address
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Vascular Surgery Research Group
Imperial College London
Charing Cross Campus
St Dunstans Road
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City/town
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London
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Zip/Postcode
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W6 8RP
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Country
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United Kingdom
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Tel
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+44 (0)20 8846 7312
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Email
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j.powell@imperial.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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Research Governance Office
Faculty of Medicine
G02 Sir Alexander Flemming Building
South Kensington Campus
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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02/12/2008
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Last edited
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09/03/2010
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Date ISRCTN assigned
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12/12/2008
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