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ISRCTN
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ISRCTN18815770
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ClinicalTrials.gov identifier
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Public title
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A trial of cerebral angioplasty for post-subarachnoid haemorrhage symptomatic vasospasm
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Scientific title
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A trial of cerebral angioplasty for post-subarachnoid haemorrhage symptomatic vasospasm: an interventional randomised controlled trial
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Acronym
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VERITAS
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Serial number at source
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N/A
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Study hypothesis
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We aim to examine the hypothesis that cerebral balloon angioplasty (CBA) and best medical treatment compared with best medical treatment alone will substantially reduce the proportion of patients with an unfavourable outcome following the development of symptomatic cerebral vasospasm with associated delayed ischaemic neurological deficit (DIND) after aneurysmal sub-arachnoid haemorrhage (ASAH).
As of 04/03/2009 this record was updated to include an amended anticipated end date; the initial anticipated end date at the time of registration was 01/12/2010.
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Lay summary
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Ethics approval
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Scottish MREC and MREC gave approval.
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Study design
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Interventional randomised controlled trial with concealed allocation and minimisation
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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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Symptomatic vasospasm post-aneurysmal subarachnoid haemorrhage
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Participants - inclusion criteria
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1. Have a documented SAH from a ruptured aneurysm
2. Ruptured aneurysm must be secured by coiling or clipping
3. Patients have developed a delayed ischaemic neurological deficit, this is defined as any one of:
3.1. Clear focal neurological deficit developing after 72 hours post ictus
3.2. Falling Glasgow Coma Score (GCS) by two or more points after 72 hours post ictus
3.3. Increasingly severe headache after 72 hours post ictus with confirmation of angiographic vasospasm
For points a + b clinical suspicion of symptomatic vasospasm should be confirmed where possible by imaging demonstration of vasospasm (this can be by any standard technique: Angiography, Trans-Cranial Doppler sonography (TCD), Single Photon Emission Computerised Tomography (SPECT), CT or Magnetic Resonance (MR) angio/perfusion)
4. Informed consent/assent in line with local and multicentre ethics approval
5. Rebleeding and hydrocephalus have been excluded on Computerised Tomography (CT) brain scan
6. Availability of CBA within 24 hours of DIND symptom onset (aim is to perform CBA as soon as possible after onset of symptomatic vasospasm - timing related to symptom onset will be recorded)
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Participants - exclusion criteria
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1. Consent unobtainable from patient (World Federation of Neurosurgical Sciences [WFNS] grade four or five, or grade three but dysphasic) or no personal or professional legal representative available to assent on their behalf
2. Another cause for deterioration/ischaemic deficit demonstrated
3. Participation in another clinical neurointerventional trial related to the management of ASAH
4. Pregnancy is also an exclusion criterion
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Anticipated start date
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01/12/2006
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Anticipated end date
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01/06/2012
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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200
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Interventions
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Cerebral balloon angioplasty and standard medical therapy versus standard medical therapy alone
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Primary outcome measure(s)
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Death/disability at three months as assessed by Modified Rankin Score (MRS) and National Institute of Health Stroke Scale (NIHSS) determined by independent 'blinded' neurologist
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Secondary outcome measure(s)
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1. Clinical outcome at one year (MRS & Euroquol instrument assessment)
2. Duration of stay in Intensive Care Unit (ICU)/hospital
3. Discharge destination
4. Requirement for extended care facilities
5. Cost assessment of CBA versus control group
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Sources of funding
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Chest, Heart & Stroke Scotland (UK) - funding for start up phase supplied
Other funders still being sought.
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Trial website
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Publications
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Contact name
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Dr
Philip
White
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Address
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Western General Hospital
Department of Clinical Neurosciences X-Ray
Crewe Road
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City/town
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Edinburgh
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Zip/Postcode
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EH4 2XU
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Country
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United Kingdom
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Tel
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+44 (0)131 537 2022
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Fax
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+44 (0)131 537 2579
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Email
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pmw@skull.dcn.ed.ac.uk
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Sponsor
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Lothian University Hospitals Division (UK)
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Address
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R&D Office Queens Medical Research Institute
47 Little France Crescent
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4TJ
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Country
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United Kingdom
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Tel
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+44 (0)131 242 3330
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Fax
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+44 (0)131 242 3343
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Email
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rachel.smith@luht.scot.nhs.uk
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Sponsor website:
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http://www.research.luht.scot.nhs.uk/
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Date applied
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29/06/2006
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Last edited
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04/03/2009
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Date ISRCTN assigned
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10/11/2006
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