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A single-center, prospective, randomized controlled exploratory clinical trial to evaluate the clinical efficacy and safety of general therapy combined with edaravone and dexcampine injection concentrated solution (Xianbizin?) in the treatment of patients with aneurysmal subarachnoid hemorrhage

A single-center, prospective, randomized controlled exploratory clinical trial to evaluate the clinical efficacy and safety of general therapy combined with edaravone and dexcampine injection concentrated solution (Xianbizin?) in the treatment of patients with aneurysmal subarachnoid hemorrhage

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057822
Enrollment
Unknown
Registered
2022-03-18
Start date
2021-07-01
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal subarachnoid hemorrhage

Interventions

Experimental group:Edaravone Dexborneol

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients older than 18 years old and younger than 70 years old; 2. Patients with aneurysmal subarachnoid hemorrhage (CTA or DSA); 3. Undergo surgical treatment within 72 hours of onset (non-interventional surgery, but craniotomy microsurgical aneurysm clipping); 4. The new treatment can be applied at least once within 48 hours of onset; 5. Hunt-Hess score <= 4; 6. Improved Fisher score 1-4 points; 7. mRS score before the onset of <= 1 point; 8. The patient's hospital stay is expected to be more than 10 days; 9. The informed consent form signed by the patient or his legal representative.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to any ingredients or excipients contained in it; 2. Patients undergoing interventional surgery; 3. Patients with subarachnoid hemorrhage caused by brain trauma, cerebral arteriovenous malformations, cerebrovascular amyloidosis and other reasons; 4. Patients with severe obstructive hydrocephalus caused by subarachnoid hemorrhage, requiring cerebrospinal fluid shunt; 5. Head CT of the admitted hospital showed that the amount of hemorrhage in the brain parenchyma>10ml; 6. Patients with a history of ischemic stroke in the past 3 months; 7. Hunt-Hess score 5 points or modified Fisher Grade 0 points; 8. Patients with unstable vital signs, deep coma, or suspected brain herniation; 9. Patients with severe heart failure; 10. Patients with severe liver and kidney failure; 11. Patients with severe respiratory failure; 12. Patients with severe coagulopathy; 13. Patients during pregnancy and lactation; 14. Patients with malignant tumors; 15. Patients with severe mental disorders or dementia; 16. Patients who are participating in other clinical research, using other research drugs or interventions; 17. Reasons why other researchers think it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Cerebral vasospasm;

Secondary

MeasureTime frame
mRS score;

Countries

China

Contacts

Public ContactGang Chen

The First Affiliated Hospital of Soochow University

gangchen@suda.edu.cn+86 13771908806

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026