Chronic Subdural Hematoma
Conditions
Keywords
Chronic subdural haematoma, Medical treatment, Atorvastatin, Clinical outcome, Surgical recurrence
Brief 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.
Detailed 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.
Interventions
DRUGAtorvastatin 20mg
20mg (every evening orally) for 8 weeks.
DRUGPlacebos
20mg (every evening orally) for 8 weeks.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years old; 2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT); 3. Patients are joining the trial voluntarily with consent form signed.
Exclusion criteria
1. Allergy to atorvastatin or other statins; 2. Deranged liver function; 3. Patients who are already on long term steroid for other condition(s); 4. Patients who are already on statin for other condition(s); 5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt); 6. Pregnant or on breast feeding; 7. Hematoma is secondary to tumour or haematological disorders; 8. Patients taking angiotensin converting enzyme (ACE) inhibitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favourable Modified Rankin Scale (mRS) score | 6 months | Modified Rankin Scale score of 0-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic subdural haematoma (CSDH) related surgical intervention | Throughout the study period, an average of 6 months | Recurrence rate in both initially non-operatively treated patients and operative cases |
Other
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index (BI) | 2 weeks, 8 weeks, 3 months, and 6 months | 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. |
| Glasgow Outcome Scale (GOS) | 2 weeks, 8 weeks, 3 months, and 6 months | 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. |
| Modified Rankin Scale | 2 weeks, 8 weeks, 3 months, and 6 months | Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury. |
| Montreal Cognitive Assessment (MoCA) | 2 weeks, 8 weeks, 3 months, and 6 months | One-page test for detecting cognitive impairment. The score ranges from 0-30 with a higher score indicating better outcome. |
| Imaging diagnosis | Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months | 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. |
Countries
Hong Kong
Contacts
Primary ContactWai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg
Outcome results
None listed