Efficacy of Atorvastatin in Chronic Subdural Haematoma (REACH)
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|ClinicalTrials.gov Identifier: NCT03956368|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Subdural Hematoma||Drug: Atorvastatin 20mg Drug: Placebos||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||690 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)|
|Actual Study Start Date :||January 9, 2020|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: Treatment Group
Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.
Drug: Atorvastatin 20mg
20mg (every evening orally) for 8 weeks.
Placebo Comparator: Control Group
Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.
20mg (every evening orally) for 8 weeks.
- Favourable Modified Rankin Scale (mRS) score [ Time Frame: 6 months ]Modified Rankin Scale score of 0-3
- Chronic subdural haematoma (CSDH) related surgical intervention [ Time Frame: Throughout the study period, an average of 6 months ]Recurrence rate in both initially non-operatively treated patients and operative cases
- Glasgow Outcome Scale (GOS) [ Time Frame: 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.
- Imaging diagnosis [ Time Frame: 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.
- Barthel Index (BI) [ Time Frame: 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.
- Montreal Cognitive Assessment (MoCA) [ Time Frame: 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.
- Modified Rankin Scale [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956368
|Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg||+852 3505 2624 / 3505 email@example.com|
|Prince of Wales Hospital||Recruiting|
|Shatin, New Territories, Hong Kong|
|Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg +852 3505 2624 / 3505 1522 firstname.lastname@example.org|
|Principal Investigator: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg|
|Sub-Investigator: David Yuen Chung Chan, MRCSEd|
|Sub-Investigator: George Kwok Chu Wong, MBChB,MD,FRCSEd,FCSHK-Surg|
|Sub-Investigator: Stephanie Chi Ping Ng, PhD|
|Sub-Investigator: William B Goggins, ScD, SM|