Contact information
Type
Scientific
Primary contact
Dr Philip White
ORCID ID
Contact details
Western General Hospital
Department of Clinical Neurosciences X-Ray
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 537 2022
pmw@skull.dcn.ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A trial of cerebral angioplasty for post-subarachnoid haemorrhage symptomatic vasospasm: an interventional randomised controlled trial
Acronym
VERITAS
Study hypothesis
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).
On 04/03/2009 the overall trial end date was changed from 01/12/2010 to 01/06/2012.
Ethics approval
Scottish MREC and MREC gave approval
Study design
Interventional randomised controlled trial with concealed allocation and minimisation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Symptomatic vasospasm post-aneurysmal subarachnoid haemorrhage
Intervention
Cerebral balloon angioplasty and standard medical therapy versus standard medical therapy alone
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/12/2006
Overall trial end date
01/06/2012
Reason abandoned
Eligibility
Participant inclusion criteria
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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
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
Recruitment start date
01/12/2006
Recruitment end date
01/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
Sponsor information
Organisation
Lothian University Hospitals Division (UK)
Sponsor details
R&D Office Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 3330
rachel.smith@luht.scot.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Chest, Heart & Stroke Scotland (UK) - funding for start up phase supplied
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Other funders still being sought.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary