Clinical trial NCT06138353: Shuxuening Injection for the Prevention of CVS in Patients With aSAH(SXN-CVS)
Official title: Shuxuening Injection for the Prevention of Cerebral Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage -- A Randomized, Double-blind, Placebo-parallel Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: aneurysmal subarachnoid hemorrhage
cerebral vasopasm
delayed cerebral ischemia
surgical clipping
coiling
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Shuxuening injection treatment : Shuxuening injection (specification: 10ml/branch, Lanzhi Group Wanrong Pharmaceutical Co., Ltd.), 20 ml (2 branches) + 5% dextrose injection 250 ml, intravenously, once a day, from the first day of postoperative aSAH, treatment for 1 course of treatment, a total of 10-14 days.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This was a randomized, double-blind, placebo-parallel controlled clinical trial.

Patients were randomly divided into 2 groups according to 1:1. Group1: Shuxuening injection treatment group (N1=25): Shuxuening injection (specification: 10ml/branch, Lonch Group Wanrong Pharmaceutical Co., Ltd.), 20 ml (2 branches) + 5% dextrose injection 250 ml, intravenously, once a day, from the first day of postoperative, treatment for 1 course of treatment, a total of 10-14 days; Group2: Placebo control group (N2=25): Shuxuening injection simulant (0.9% sodium chloride injection, specification: 10ml/cartridge, Kunming Yusi Pharmaceutical Co., Ltd.), 20 ml (2 cartridges) + 5% dextrose injection 250 ml, intravenously once a day, from the first day of postoperative, treatment for 1 course of treatment, for a total of 10-14 days; both groups received the basal treatment.

Basic treatment included nimodipine (oral nimodipine, 60 mg, 4 hours/dose), oxygen inhalation,blood pressure and cardiac monitoring, fluid balance and blood glucose management, etc., in accordance with the "2023 American Heart Association/American Stroke Association (AHA/ASA) Guidelines for the Management of Patients with Aneurysmal Subarachnoid Haemorrhage". Patients will be classified according to the Hunt-Hess grade, with H-H I-II grade placed in the general ward and III-V grade placed in the intensive care unit(ICU).

Eligibility criteria: Inclusion Criteria:

1. adult patients (\> 18 years of age)
2. patients who were diagnosed with aneurysmal subarachnoid hemorrhage
3. the aneurysms were treated by microsurgery clipping or endovascular coiling
4. Time from onset to surgery is less than or equal to 72 hours;
5. no new hemorrhage or new infarction on first postoperative CT;
6. signed informed consent.

Exclusion Criteria:

1. mRS \>1 before onset
2. history of microsurgery clipping or endovascular coiling
3. anemia (hemoglobin \<10g/dL), thrombocytopenia (platelet count \<100×10\^9/L), or leukopenia (white blood cell count \<3×10\^9/L) at randomization
4. patients with chronic liver and kidney dysfunction (including those with alanine aminotransferase (ALT) and aliquot aminotransferase (AST) \> 3 times the upper limit of normal, and those with blood creatinine (Scr) \> 2 times the upper limit of normal)
5. patients suffering from cardiorespiratory insufficiency disease such as heart failure, severe heart disease, respiratory failure
6. allergy to Shuxuening Injection
7. those who have used Shuxuening Injection before enrolled
8. patients with end-stage disease, those with a life expectancy of less than 3 months
9. women who are prepare for pregnancy in 3 months, pregnant or breastfeeding
10. those who are participating or have participated in other clinical trials within the past 1 month
11. patients are unable to comply with this study due to mental illness, cognitive or emotional disorders, etc. or that the investigator think patients inappropriate for this study

Primary outcomes:
measure: Number of Participants with cerebral vasospasm(CVS)
timeFrame: Cerebral vasospasm events within 14 days
Secondary outcomes:
measure: Rate of Delayed Cerebral Ischemic(DCI)
timeFrame: Delayed cerebral ischemic events within 14 days
Other outcomes:
measure: modified Rankin scale(mRS)
timeFrame: modified Rankin scale(mRS) within 14 days and 90 days
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
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