A Phase 3 interventional study of Atorvastatin 20mg and Placebos in Chronic Subdural Hematoma, sponsored by Chinese University of Hong Kong. Status unknown at 7 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Chinese University of Hong Kong · Phase 3, Interventional, and Treatment
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.
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.
99 studies on the registry are indexed under Hematoma, Subdural; 29 are open to participants now.
This study's planned enrollment of 690 is above the median of 100 across 73 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.
Drug: Atorvastatin 20mg
Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.
Drug: Placebos
20mg (every evening orally) for 8 weeks.
20mg (every evening orally) for 8 weeks.
Favourable Modified Rankin Scale (mRS) score
Modified Rankin Scale score of 0-3
Time frame: 6 months
Chronic subdural haematoma (CSDH) related surgical intervention
Recurrence rate in both initially non-operatively treated patients and operative cases
Time frame: Throughout the study period, an average of 6 months
Glasgow Outcome Scale (GOS)
Gross clinical outcome measure which allows standardised descriptions (good recovery, moderate disability, severe disability, persistent vegetative state, and death, with good recovery indicating the best outcome and death indicating the worst) for the degree of recovery in patients with brain damage.
Time frame: 2 weeks, 8 weeks, 3 months, and 6 months
Imaging diagnosis
Computed Tomography (CT) brain scan to exclude the presence of air and new blood in subdural space at 1-2 weeks and to elevate the clarification of CSDH resolution at 3 months and 6 months.
Time frame: Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months
Barthel Index (BI)
Ordinal scale used to measure performance in activities of daily living (ADL) which uses 10 variables describing ADL and mobility. Scores range from 0-100 with 0 indicating the worst outcome and 100 indicating the best outcome.
Time frame: 2 weeks, 8 weeks, 3 months, and 6 months
Montreal Cognitive Assessment (MoCA)
One-page test for detecting cognitive impairment. The score ranges from 0-30 with a higher score indicating better outcome.
Time frame: 2 weeks, 8 weeks, 3 months, and 6 months
Modified Rankin Scale
Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury.
Time frame: 2 weeks, 8 weeks, 3 months, and 6 months
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong