Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06138353
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-11-08
Brief Title:
Shuxuening Injection for the Prevention of CVS in Patients With aSAHSXN-CVS
Sponsor:
Xiaolin Chen MD
Organization:
Beijing Tiantan Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SXN-CVS
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 annuallyAn 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 intraoperativeThe 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 eventsShuxuening 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 10mlbranch for the prophylactic of cerebral vasospasm CVS after aneurysmal subarachnoid hemorrhage
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 intraoperativeThe 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 eventsShuxuening 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 10mlbranch 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 11 Group1 Shuxuening injection treatment group N125 Shuxuening injection specification 10mlbranch 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 N225 Shuxuening injection simulant 09 sodium chloride injection specification 10mlcartridge 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 hoursdose oxygen inhalationblood pressure and cardiac monitoring fluid balance and blood glucose management etc in accordance with the 2023 American Heart AssociationAmerican Stroke Association AHAASA 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 unitICU
Patients were randomly divided into 2 groups according to 11 Group1 Shuxuening injection treatment group N125 Shuxuening injection specification 10mlbranch 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 N225 Shuxuening injection simulant 09 sodium chloride injection specification 10mlcartridge 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 hoursdose oxygen inhalationblood pressure and cardiac monitoring fluid balance and blood glucose management etc in accordance with the 2023 American Heart AssociationAmerican Stroke Association AHAASA 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 unitICU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None