Abstract
BackgroundChronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve outcomes, presumably by reducing local inflammation and promoting vascular repair. We wish to extend this evidence in a study that aims to determine the efficacy and safety of atorvastatin combined with low-dose dexamethasone in patients with CSDH.MethodsThe second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-centre, randomized, placebo-controlled, double-blind trial which aims to enrol 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition and reduction in haematoma volumes at 14, 28 and 90 days.DiscussionThis multi-centre clinical trial aims to provide high-quality evidence on the efficacy and safety of the combined treatment of atorvastatin and low-dose dexamethasone to reduce inflammation and enhance angiogenesis in CSDH.Trial registrationChiCTR, ChiCTR1900021659. Registered on 3 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=36157.
Highlights
Background and rationale {6a} Chronic subdural haematoma (CSDH) represents one of the most common forms of intracranial haemorrhage, causing a variety of diagnostic and therapeutic challenges as rates increase in ageing populations and increased use of antithrombotic agents [1, 2]
The study sponsors and funders had no role in the design, execution, analyses, interpretation of data, or decision to submit results for this study dexamethasone combined with low-dose atorvastatin in patients with CSDH
We initiated the second Atorvastatin combined with dexamethasone in Chronic subdural Haematoma (ATOCH-II) trial to determine the efficacy and safety of Research question The primary aim of ATorvastatin On Chronic subdural Hematoma (ATOCH)-II is to determine whether the combination of low-dose atorvastatin and low-dose dexamethasone is superior to low-dose atorvastatin alone on the composite outcome of haematoma volume, transition to surgery and death at 28 days in patients with CSDH
Summary
The second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-centre, randomized, placebo-controlled, double-blind trial which aims to enrol 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition and reduction in haematoma volumes at 14, 28 and 90 days
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