International Subarachnoid Aneurysm Trial

ISRCTN	ISRCTN49866681
DOI	https://doi.org/10.1186/ISRCTN49866681
Secondary identifying numbers	G9401611

Submission date: 23/10/2000
Registration date: 23/10/2000
Last edited: 11/03/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Dr Andrew J Molyneux
Scientific

Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
West Wing, Level 6
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 234755
Email	andy.molyneux@nds.ox.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	International Subarachnoid Aneurysm Trial
Study acronym	ISAT
Study hypothesis	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)
Ethics approval(s)	Not provided at time of registration
Condition	Neuroscience, psychiatry
Intervention	1. Endovascular treatment policy of ruptured intracranial aneurysms 2. A conventional neurosurgical treatment policy
Intervention type	Procedure/Surgery
Primary outcome measure	Modified Ranking scale, Glasgow outcome scale, Neuropsychology assessment in some centres. Euroquol quality of life assessment, health economic evaluation including back to work rates
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1997
Overall study end date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2143
Participant inclusion criteria	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
Participant exclusion criteria	1. More than 28 days from SAH, unproven SAH 2. Unsuitable for both treatments 3. Refusal of consent 4. Patient participating in another trial
Recruitment start date	01/01/1997
Recruitment end date	31/12/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)

Oxford
OX3 9DU
United Kingdom

Sponsor information

Oxford Radcliffe Hospital NHS Trust (UK)
Hospital/treatment centre

John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
England
United Kingdom

Website	http://www.oxfordradcliffe.nhs.uk/home.aspx
"ROR"	https://ror.org/03h2bh287

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/09/2005	Yes	No
Results article	results	01/08/2010	Yes	No
Results article	results	01/12/2011	Yes	No
Results article	results	21/02/2015	Yes	No