Efficacy of Atorvastatin in Chronic Subdural Haematoma

  • STATUS
    Recruiting
  • End date
    Oct 31, 2021
  • participants needed
    690
  • sponsor
    Chinese University of Hong Kong
Updated on 27 January 2021

Summary

This prospective, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of atorvastatin in patients with chronic subdural haematoma. The degree of disability or dependence in daily activities, as well as surgical intervention or recurrence, of the treatment and control groups will be compared.

Description

Objectives: Chronic subdural haematoma (CSDH) is a common neurosurgical condition in the elderly population associated with mild head injury. Surgical drainage has been regarded as safe and effective. However, surgical complications including recurrences can result in poor functional outcome and fatality, particularly in the elderly patients. Atorvastatin, an HMGCoA reductase inhibitor and a widely prescribed lipid lowering medication has properties of inflammation modulation and neovasculature promotion.

Hypothesis: Atorvastatin can improve functional outcome in patients with CSDH for both initially non-operatively treated group (estimated to be 10%) and the operative group (90%) by reducing the rate of surgical intervention and recurrence rate.

Design: A prospective multicentre study of 690 consented patients with symptomatic CSDH will be randomised on the day of admission to receive atorvastatin 20 mg or a placebo daily for 8 weeks. All seven regional neurosurgical units in Hong Kong and two units outside Hong Kong, each treating 80-200 patients per annum, have been invited to participate.

Main Outcome Measures: Primary outcome: Modified Rankin Scale (mRS). Secondary outcome: surgical recurrence.

Sample Size: Assuming an absolute 10% improvement in favourable outcome in the Modified Rankin Scale score (mRS 0-3) at 6 months from the control group of 70% to the treatment group 80%, allowing a 10% loss to follow up, a sample size of 690 is required.

Expected Results: A successful study for improving clinical outcome of CSDH, an important illness of the elderly with an annual incidence of 58/100,000 will change clinical practice.

Details
Condition Chronic subdural hematoma
Treatment placebos, Atorvastatin 20mg
Clinical Study IdentifierNCT03956368
SponsorChinese University of Hong Kong
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic subdural hematoma?
Do you have any of these conditions: Do you have Chronic subdural hematoma??
Do you have any of these conditions: Do you have Chronic subdural hematoma??
Do you have any of these conditions: Do you have Chronic subdural hematoma??
Age greater than or equal to 18 years old
Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT)
Patients are joining the trial voluntarily with consent form signed

Exclusion Criteria

Allergy to atorvastatin or other statins
Deranged liver function
Patients who are already on long term steroid for other condition(s)
Patients who are already on statin for other condition(s)
Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt)
Pregnant or on breast feeding
Hematoma is secondary to tumour or haematological disorders
Patients taking angiotensin converting enzyme (ACE) inhibitor
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