A trial of cerebral angioplasty for post-subarachnoid haemorrhage symptomatic vasospasm
| ISRCTN | ISRCTN18815770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18815770 |
| Protocol serial number | N/A |
| Sponsor | Lothian University Hospitals Division (UK) |
| Funders | Chest, Heart & Stroke Scotland (UK) - funding for start up phase supplied, Other funders still being sought. |
- 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
Scientific
Western General Hospital
Department of Clinical Neurosciences X-Ray
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
| Phone | +44 (0)131 537 2022 |
|---|---|
| pmw@skull.dcn.ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised controlled trial with concealed allocation and minimisation |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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 |
| Key secondary outcome measure(s) |
1. Clinical outcome at one year (MRS & Euroquol instrument assessment) |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
EH4 2XU
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 |
Editorial Notes
10/08/2017: No publications found in PubMed, verifying study status with principal investigator.
