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Clinical study of the efficacy and safety of combining atorvastatin and dexamethasone in the treatment of chronic subdural hematoma after drilling and drainage

Clinical study of the efficacy and safety of combining atorvastatin and dexamethasone in the treatment of chronic subdural hematoma after drilling and drainage

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030156
Enrollment
Unknown
Registered
2020-02-24
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

Chronic subdural Hematoma

Interventions

simple drilling group:routine neurosurgical monitoring and treatment after drilling
the atorvastatin group:oral atorvastatin 20mg (1 tablet) Qd for 28 days.
combine atorvastatin and dexamethasone group:On days 1-14, atorvastatin 20mg (1 tablet) Qd and dexamethasone 0.75mg (1 tablet) Tid
on days 15-21, atorvastatin 20mg (1 tablet) Qd and dexamethasone 0.75mg (1 tablet) Bid
On days 22-28, atorvastatin 20 mg (1 tablet) Qd and dexamethasone 0.75 mg (1 tablet) Qd.

Sponsors

Haining People's Hospital, Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Aged >= 18 years and < 90 years, no gender restriction; (2) Within 72 hours before enrollment in the experiment, CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); a single unilateral hematoma should be greater than 10ml; (3) No cerebral hernia; (4) Chronic cranial pressure or cerebral compression manifestations, such as: headache, vomiting, optic disc edema, mental Intellectual disability, epilepsy, neurolocalization signs, etc .; (5) No severe systemic disease that constitutes a contraindication to surgery, including those with severe coagulopathy; (6) Those who can follow up for more than 3 months after surgery; (7) All patients sign informed consent.

Exclusion criteria

Exclusion criteria: (1) There are severe abnormalities in heart, lung, liver, and kidney function, which affect the overall prognosis of patients; (2) Postoperative coagulopathy or liver dysfunction that is not related to surgery, as well as suffering from other disease may interfere the study; (3) Head injury during follow-up period; (4) Contraindications for the use of atorvastatin and dexamethasone; (5) Poor blood glucose control, and fasting blood glucose continued to be greater than 10mmol / L; (6) History of oral statins within 4 weeks before the trial; (7) History of oral steroid hormones within 4 weeks before the trial; (8) Female patients during pregnancy or lactation; (9) Poor compliance and unable to complete the trial according to the research protocol.

Design outcomes

Primary

MeasureTime frame
Hematoma recurrence rate;

Secondary

MeasureTime frame
Complication rate;Neurological recovery;

Countries

China

Contacts

Public ContactChen Weiliang

Haining People's Hospital

497425408@qq.com+86 15505281937

Outcome results

None listed

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