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

NCT06138353 | Recruiting Phase 2 DMC

• 1 other identifier: HX-A-2023023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

aneurysmal subarachnoid hemorrhage; cerebral vasopasm; delayed cerebral ischemia; surgical clipping; coiling

Outcome Measures

Primary Outcomes (1)

• Number of Participants with cerebral vasospasm(CVS)

  The prevalence of CVS after aSAH is 67% , with symptomatic patients (symptomatic vasospasm) in 30-40% of them and leading to ischemic events in 10-45% of patients. It usually begins 3-4 days after rupture bleeding, peaks at 7-10 days and finally resolves at around 14-21 days.

  Cerebral vasospasm events within 14 days

Secondary Outcomes (1)

• Rate of Delayed Cerebral Ischemic(DCI)

  Delayed cerebral ischemic events within 14 days

Other Outcomes (1)

• modified Rankin scale(mRS)

  modified Rankin scale(mRS) within 14 days and 90 days

Study Arms (2)

Shuxuening injection treatment group

EXPERIMENTAL

Group1: Shuxuening injection treatment group (N1=25): 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, treatment for 1 course of treatment, a total of 10-14 days.

Drug: Shuxuening injection or placebo

Placebo control group

PLACEBO COMPARATOR

Group2: Placebo control group (N2=25): Shuxuening injection simulant (0.9% sodium chloride injection, specification: 10 ml/cartridge, Kunming Yusi Pharmaceutical Co., Ltd.), 20 ml (2 cartridges) + 5% dextrose injection 250 ml, intravenously dripped once a day, from the first day of postoperative, treatment for 1 course of treatment, for a total of 10-14 days.

Drug: Shuxuening injection or placebo

Interventions

Shuxuening injection or placebo DRUG

Shuxuening injection treatment group : 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, treatment for 1 course of treatment, a total of 10-14 days.

Placebo control group; Shuxuening injection treatment group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• mRS \>1 before onset
• history of microsurgery clipping or endovascular coiling
• anemia (hemoglobin \<10g/dL), thrombocytopenia (platelet count \<100×10\^9/L), or leukopenia (white blood cell count \<3×10\^9/L) at randomization
• 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)
• patients suffering from cardiorespiratory insufficiency disease such as heart failure, severe heart disease, respiratory failure
• allergy to Shuxuening Injection
• those who have used Shuxuening Injection before enrolled
• patients with end-stage disease, those with a life expectancy of less than 3 months
• women who are prepare for pregnancy in 3 months, pregnant or breastfeeding
• those who are participating or have participated in other clinical trials within the past 1 month
• 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

Sponsors & Collaborators

• Xiaolin Chen, MD: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (9)

• Dankbaar JW, de Rooij NK, Velthuis BK, Frijns CJ, Rinkel GJ, van der Schaaf IC. Diagnosing delayed cerebral ischemia with different CT modalities in patients with subarachnoid hemorrhage with clinical deterioration. Stroke. 2009 Nov;40(11):3493-8. doi: 10.1161/STROKEAHA.109.559013. Epub 2009 Sep 17.

  PMID: 19762703 RESULT

• Macdonald RL, Schweizer TA. Spontaneous subarachnoid haemorrhage. Lancet. 2017 Feb 11;389(10069):655-666. doi: 10.1016/S0140-6736(16)30668-7. Epub 2016 Sep 13.

  PMID: 27637674 RESULT

• Westermaier T, Jauss A, Eriskat J, Kunze E, Roosen K. Acute vasoconstriction: decrease and recovery of cerebral blood flow after various intensities of experimental subarachnoid hemorrhage in rats. J Neurosurg. 2009 May;110(5):996-1002. doi: 10.3171/2008.8.JNS08591.

  PMID: 19061352 RESULT

• Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.

  PMID: 20798370 RESULT

• Geraghty JR, Testai FD. Delayed Cerebral Ischemia after Subarachnoid Hemorrhage: Beyond Vasospasm and Towards a Multifactorial Pathophysiology. Curr Atheroscler Rep. 2017 Oct 23;19(12):50. doi: 10.1007/s11883-017-0690-x.

  PMID: 29063300 RESULT

• Macdonald RL. Delayed neurological deterioration after subarachnoid haemorrhage. Nat Rev Neurol. 2014 Jan;10(1):44-58. doi: 10.1038/nrneurol.2013.246. Epub 2013 Dec 10.

  PMID: 24323051 RESULT

• Mahadevan S, Park Y. Multifaceted therapeutic benefits of Ginkgo biloba L.: chemistry, efficacy, safety, and uses. J Food Sci. 2008 Jan;73(1):R14-9. doi: 10.1111/j.1750-3841.2007.00597.x.

  PMID: 18211362 RESULT

• Calapai G, Crupi A, Firenzuoli F, Marciano MC, Squadrito F, Inferrera G, Parisi A, Rizzo A, Crisafulli C, Fiore A, Caputi AP. Neuroprotective effects of Ginkgo biloba extract in brain ischemia are mediated by inhibition of nitric oxide synthesis. Life Sci. 2000 Oct 20;67(22):2673-83. doi: 10.1016/s0024-3205(00)00858-4.

  PMID: 11105983 RESULT

• Tulsulkar J, Shah ZA. Ginkgo biloba prevents transient global ischemia-induced delayed hippocampal neuronal death through antioxidant and anti-inflammatory mechanism. Neurochem Int. 2013 Jan;62(2):189-97. doi: 10.1016/j.neuint.2012.11.017. Epub 2012 Dec 7.

  PMID: 23228346 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

shuxuening

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jun Yang, doctoral

CONTACT

010-18911127316; yangjun4780@163.com

Xiaolin Chen, doctoral

CONTACT

010-13810624845; cxl_bjtth@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: To ensure blinding, personnel involved in randomisation coding or with potential access to the blind base, doctors or nurses administering the medication, should not be involved in activities such as selection of subjects, evaluation of efficacy, and assessment of safety, so as not to introduce bias. In addition, to ensure blinding, the packaging and batch numbers of the drugs in both groups will be identical, and the packaging batch numbers will be uniformly labelled. Each box will be labelled with a unique drug ID number. This number will be used to designate the treatment received by the patient, but will not indicate treatment assignment to the investigator or the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Neurosurgery

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: January 24, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)