Shuxuening Injection for the Prevention of CVS in Patients With aSAH(SXN-CVS)
Status:
Recruiting
Trial end date:
2025-11-30
Target enrollment:
Participant gender:
Summary
Aneurysmal subarachnoid hemorrhage (SAH) is a frequent worldwide cause for stroke with a
mortality of around 30%. Worldwide, almost 500 000 patients have aneurysmal SAH annually.An
incidence of 2-16 cases of spontaneous SAH per 100 000 person-years was reported in a recent
meta-analysis .
Surgical treatment of aneurysms is essential in the acute phase of aSAH patients, either by
surgical clipping or by endovascular embolization. Although there are many factors that
influence the prognosis of patients with aSAH, cerebral vasospasm (CVS) and delayed cerebral
ischemia (DCI) are the main factors contributing to the high mortality rate (30-40% within 30
days) and poor long-term functional prognosis of patients after aSAH. Cerebral vasospasm
(CVS) is defined as focal or diffuse temporary narrowing of vessel diameter due to
contraction of smooth muscle in the arterial wall, which can be detected by digital
subtraction angiography (DSA), transcranial ultrasound Doppler (TCD), magnetic resonance
(MR), and CT angiography (CTA) or visualised during intraoperative.The prevalence of CVS
after aSAH is 67% , with symptomatic patients (symptomatic vasospasm) in 30-40% of them and
leading to ischaemic events in 10-45% of patients. It usually begins 3-4 days after bleeding,
peaks at 7-10 days and finally resolves at around 14-21 days.
There is no effective treatment to prevent cerebral vasospasm events.Shuxuening Injection is
a sterilized aqueous solution made by extraction of Ginkgo biloba. The study aims to clarify
the clinical study of the efficacy and safety of Shuxuening Injection (10ml/branch) for the
prophylactic of cerebral vasospasm (CVS) after aneurysmal subarachnoid hemorrhage.