Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma

Launched by BEIJING TIANTAN HOSPITAL · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a Chinese herbal formula called HuoXue LiShui for treating chronic subdural hematomas (CSDH), which are collections of blood on the brain that can cause various health issues. The trial aims to see whether this herbal treatment can help reduce the need for surgery or prevent the hematoma from coming back in patients. It will involve comparing the results of patients receiving the herbal treatment with those receiving a placebo (a treatment that looks the same but has no active ingredients) over a 24-week period.

To participate, individuals must be between 18 and 90 years old and diagnosed with certain types of CSDH confirmed by imaging tests like a CT scan or MRI. They should have stable vital signs and mild neurological symptoms. However, those with serious health issues, recent surgeries, or specific medical conditions, such as severe liver or kidney problems, cannot join the study. Participants will need to provide written consent, and they can expect to be monitored closely throughout the trial to assess their health and treatment outcomes. If you or a loved one meets the eligibility criteria, this trial could offer an opportunity to explore a new treatment option for managing chronic subdural hematomas.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 90 years and either gender will be included.
• • 2. Supratentorial, unilateral or bilateral CSDHs will be verified via cranial CT or magnetic resonance imaging (MRI).
• • 3. Primary hematoma or residual hematoma after burr-hole drainage.
• • 4. Stable vital signs and neurological deficits are indicated by a Glassgow Coma Scale (GCS) score ≥ 14 and a modified Rankin scale (mRS) score ≤ 2.
• • 5. No risk of brain herniation or recent immediate need for surgery will be evaluated by 2 attending neurosurgeons.
• • 6. Written informed consent will be obtained from patients or their next of kins according to their cognitive status.
• Exclusion Criteria:
• • 1. Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.
• • 2. Progressive or apparent neurological deficit with a GCS score \< 14 or mRS score \> 2.
• • 3. Midline shift \> 10 mm on the radiological image.
• • 4. Previous medication treatment for CSDH.
• • 5. Previous intracranial surgery for any other neurological disorder.
• • 6. Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.
• • 7. Known hypersensitivity or allergy to HXLS or to any of the ingredients.
• • 8. Malignant tumors.
• • 9. Life expectancy of \< 1 year.
• • 10. Abnormal liver function or liver diseases, including uncontrolled hepatitis (alanine transaminase \> 120 U/L).
• • 11. Severe renal impairment (estimated glomerular filtration rate \< 30 ml/min or serum creatinine \> 150 μmol/L).
• • 12. Moderate or severe anemia (hemoglobin ≤ 90 g/L).
• • 13. Severe coagulopathy or a high risk of life-threatening bleeding.
• • 14. Poor medication conditions or the presence of severe comorbidities such that treatment cannot be tolerated or follow-up cannot be completed.
• • 15. Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, angiotensin-converting enzyme inhibitors, or other traditional Chinese medicines before randomization or are expected to take such medications in the next 24 weeks.
• • 16. Difficulty swallowing oral medication.
• • 17. Pregnancy or lactation.
• • 18. Participating in another study.