A trial of cerebral angioplasty for post-subarachnoid haemorrhage symptomatic vasospasm: an interventional randomised controlled trial

othian University Hospitals Division (UK)0 个研究点目标入组 200 人开始时间: 2006年11月10日最近更新: 2017年9月4日

适应症

试验速览

暂无简介。

•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)

•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

发起方

othian University Hospitals Division (UK)