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NCT06138353: SXN-CVS

Shuxuening Injection for the Prevention of CVS in Patients With aSAH(SXN-CVS)

Status unknown Phase 2, PHASE3 Last updated 1 April 2024
What this trial tests

Phase 2, PHASE3 trial testing Shuxuening injection or placebo in Subarachnoid Hemorrhage, Aneurysmal in 50 participants. Status unknown.

Timeline
24 January 2024
Primary endpoint
30 November 2025
30 November 2025

Quick facts

Lead sponsorXiaolin Chen, MD
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment50
Start date24 January 2024
Primary completion30 November 2025
Estimated completion30 November 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xiaolin Chen, MD — full company profile →

Who can join

Adults 18 to 99, any sex, with Subarachnoid Hemorrhage, Aneurysmal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Beyond the bleed: complications after aneurysmal subarachnoid hemorrhage. Pathophysiology, clinical implications, and management strategies: a review.
    Busl KM, Bogossian EG, Claassen J, Helbok R, et al · · 2025 · cited 4× · PMID 41029753 · DOI 10.1186/s13054-025-05640-z

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Other recruiting trials for Subarachnoid Hemorrhage, Aneurysmal

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Data sources for this page

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