Status:
RECRUITING
Shuxuening Injection for the Prevention of CVS in Patients With aSAH(SXN-CVS)
Lead Sponsor:
Xiaolin Chen, MD
Conditions:
Subarachnoid Hemorrhage, Aneurysmal
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
PHASE3
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 c...
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): S...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06138353
Start Date
January 24 2024
End Date
November 30 2025
Last Update
April 1 2024
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070