Clinical trial NCT06427980: Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma
Official title: Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma: a a Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Chronic Subdural Hematoma
Chinese herbal formula
HuoXue LiShui
Pharmacotherapy
Randomized controlled trial
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.

Detailed description: The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of the Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH in an effort to prevent surgery. The investigators hypothesize that, compared with placebo, the Chinese herbal formula HXLS reduce incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH. Consequently, the defined null hypothesis will be that there is no difference between the groups. In total, 160 patients will be randomly assigned to the HXLS group and the placebo group at a 1:1 ratio.

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.

Primary outcomes:
measure: Rate of operation
timeFrame: From baseline up to 24 weeks after the start of treatment with the study medication
Secondary outcomes:
measure: Chronic subdural hematoma volume
timeFrame: At baseline, and at 4, 8 and 24 weeks
measure: Change of Modified Rankin Scale (MRS) between group
timeFrame: At baseline, and at 4, 8, and 24 weeks
measure: Change of Markwalder Grading Scale (MGS) between groups
timeFrame: At baseline, and at 4, 8, and 24 weeks
measure: Change of Quality of life
timeFrame: At baseline, and at 4, 8, and 24 weeks
measure: Change of performance in activities of daily living
timeFrame: At baseline, and at 4, 8, and 24 weeks
measure: Change of cognitive functioning
timeFrame: At baseline, and at 4, 8, and 24 weeks
measure: Number of falling incidents
timeFrame: At 24 weeks
measure: Mortality
timeFrame: At 24 weeks
measure: Rate of complications and adverse events between groups
timeFrame: Within 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Lianyungang
country: China
facility: First People's Hospital of Lianyungang
state: Jiangsu
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Weiming Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: