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ISRCTN
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ISRCTN49866681
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DOI
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10.1186/ISRCTN49866681
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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International Subarachnoid Aneurysm Trial
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Scientific title
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Acronym
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ISAT
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Serial number at source
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G9401611
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Study hypothesis
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To compare the safety and efficacy of an endovascular treatment policy of ruptured intracranial aneurysms with a conventional neurosurgical treatment policy in an eligible population.
Primary objective: To determine whether an endovascular treatment policy of acutely ruptured intracranial aneurysms compared with a neurosurgical treatment policy, reduces the proportion of patients with a moderate or poor outcome (defined by Rankin grade 3-6 ) by 25% at one year.
Secondary objectives: To determine if:
1. This is as effective as neurosurgery in preventing re-bleeding from the treated aneurysm including long-term follow up
2. This results in a better quality of life than neurosurgery at one year (Euroquol measure)
3. This is more cost effective than neurosurgical treatment
4. This improves the neuropsychological outcome at one year (selected centres only)
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled 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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Neuroscience, psychiatry
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Participants - inclusion criteria
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1. Proven subarachnoid haemorrhage (SAH) on Computed Tomography (CT) or lumbar puncture
2. Presence of an intracranial aneurysm demonstrated by intra-arterial angiography likely to be responsible for the SAH
3. The patient in a clinical state that justifies treatment at some time by either surgical or endovascular means
4. Intracranial aneurysm judged to be suitable for either technique based on its angiographic anatomy and the responsible clinician is uncertain which is the best method of treatment
5. Appropriate consent of the patient or relatives
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Participants - exclusion criteria
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1. More than 28 days from SAH, unproven SAH
2. Unsuitable for both treatments
3. Refusal of consent
4. Patient participating in another trial
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Anticipated start date
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01/01/1997
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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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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2143
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Interventions
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1. Endovascular treatment policy of ruptured intracranial aneurysms
2. A conventional neurosurgical treatment policy
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Primary outcome measure(s)
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Modified Ranking scale, Glasgow outcome scale, Neuropsychology assessment in some centres. Euroquol quality of life assessment, health economic evaluation including back to work rates
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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http://www.surgery.ox.ac.uk/nvru/isat
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Publications
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1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16139655
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20616321
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21819189
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Contact name
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Dr
Andrew J
Molyneux
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Address
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Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
West Wing, Level 6
John Radcliffe Hospital
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Tel
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+44 (0)1865 234755
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Fax
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+44 (0) 1865 234757
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Email
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andy.molyneux@nds.ox.ac.uk
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Sponsor
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Oxford Radcliffe Hospital NHS Trust (UK)
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Address
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John Radcliffe Hospital
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Sponsor website:
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http://www.oxfordradcliffe.nhs.uk/home.aspx
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Date applied
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23/10/2000
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Last edited
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31/01/2012
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Date ISRCTN assigned
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23/10/2000
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