A trial of cerebral angioplasty for post-subarachnoid haemorrhage symptomatic vasospasm

ISRCTN	ISRCTN18815770
DOI	https://doi.org/10.1186/ISRCTN18815770
Secondary identifying numbers	N/A

Submission date: 29/06/2006
Registration date: 10/11/2006
Last edited: 10/08/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Philip White
Scientific

Western General Hospital
Department of Clinical Neurosciences X-Ray
Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Phone	+44 (0)131 537 2022
Email	pmw@skull.dcn.ed.ac.uk

Study information

Study design	Interventional randomised controlled trial with concealed allocation and minimisation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A trial of cerebral angioplasty for post-subarachnoid haemorrhage symptomatic vasospasm: an interventional randomised controlled trial
Study acronym	VERITAS
Study objectives	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(s)	Scottish MREC and MREC gave approval
Health condition(s) or problem(s) studied	Symptomatic vasospasm post-aneurysmal subarachnoid haemorrhage
Intervention	Cerebral balloon angioplasty and standard medical therapy versus standard medical therapy alone
Intervention type	Other
Primary outcome measure	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 study start date	01/12/2006
Completion date	01/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key 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)
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	01/06/2012

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Western General Hospital

Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Lothian University Hospitals Division (UK)
University/education

R&D Office Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone	+44 (0)131 242 3330
Email	rachel.smith@luht.scot.nhs.uk
Website	http://www.research.luht.scot.nhs.uk/
"ROR"	https://ror.org/03q82t418

Funders

Funder type

Charity

Chest, Heart & Stroke Scotland (UK) - funding for start up phase supplied

No information available

Other funders still being sought.

No information available

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

Editorial Notes

10/08/2017: No publications found in PubMed, verifying study status with principal investigator.