International Subarachnoid Aneurysm Trial
| ISRCTN | ISRCTN49866681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49866681 |
| Protocol serial number | G9401611 |
| Sponsor | Oxford Radcliffe Hospital NHS Trust (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Andrew J Molyneux
Scientific
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 |
|---|---|
| andy.molyneux@nds.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | International Subarachnoid Aneurysm Trial |
| Study acronym | ISAT |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Neuroscience, psychiatry |
| Intervention | 1. Endovascular treatment policy of ruptured intracranial aneurysms 2. A conventional neurosurgical treatment policy |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Modified Ranking scale, Glasgow outcome scale, Neuropsychology assessment in some centres. Euroquol quality of life assessment, health economic evaluation including back to work rates |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 2143 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
