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

Not Applicable

Completed

• Conditions: Symptomatic vasospasm post-aneurysmal subarachnoid haemorrhage; Circulatory System; Cerebrovasular diseases

• Registration Number: ISRCTN18815770
• Lead Sponsor: othian University Hospitals Division (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-10
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Clinical outcome at one year (MRS & Euroquol instrument assessment)<br>2. Duration of stay in Intensive Care Unit (ICU)/hospital<br>3. Discharge destination<br>4. Requirement for extended care facilities<br>5. Cost assessment of CBA versus control group