Condition category
Circulatory System
Date applied
29/06/2006
Date assigned
10/11/2006
Last edited
14/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.research.luht.scot.nhs.uk/

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

Publication citations

Additional files

Editorial Notes