Using Shuxuening Injection to Prevent Complications After Aneurysmal Subarachnoid Hemorrhage
Shuxuening Injection for the Prevention of Cerebral Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage -- A Randomized, Double-blind, Placebo-parallel Controlled Clinical Trial
This study is testing if a new injection called Shuxuening can help prevent complications like brain swelling in patients who have just had surgery for a brain bleed.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06138353 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Shuxuening injection in preventing cerebral vasospasm and delayed cerebral ischemia in patients who have undergone treatment for aneurysmal subarachnoid hemorrhage. It is a randomized, double-blind, placebo-controlled trial where participants are divided into two groups: one receiving the Shuxuening injection and the other receiving a placebo. Both groups will also receive standard care as per the latest guidelines. The treatment will be administered intravenously for 10-14 days starting from the first day post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with aneurysmal subarachnoid hemorrhage and have undergone surgical treatment within 72 hours of onset.
Not a fit: Patients with pre-existing severe health conditions or those who have had prior surgeries for aneurysms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of complications and improve recovery outcomes for patients with aneurysmal subarachnoid hemorrhage.
How similar studies have performed: While there have been studies on cerebral vasospasm treatments, the specific use of Shuxuening injection in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Beijing Tiantan Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jun Yang, doctoral
- Email: yangjun4780@163.com
- Phone: 010-18911127316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.