Atorvastatin combined with dexamethasone in chronic subdural haematoma (ATOCH II): study protocol for a randomized controlled trial

Abstract

Background Chronic 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. Methods 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. Discussion This 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 registration ChiCTR, ChiCTR1900021659. Registered on 3 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=36157.

Multimodality management for chronic subdural hematoma in China: protocol and characteristics of an ambidirectional, nationwide, multicenter registry study

“…However, given the limited sample size, this proof-of-concept clinical trial lacks credibility. Nevertheless, given these promising results, trials evaluating the synergistic effect of these two drugs in CSDH treatment are currently underway [ 17 ].…”

Commentary: Recurrent Chronic Subdural Hematoma After Burr-Hole Surgery and Postoperative Drainage: A Systematic Review and Meta-Analysis

“…The fundamental question is when confronted with a CSDH, what to choose from a menu of multiple medical (dexamethasone, tranexamic acid, and NSAIDS), endovascular (middle meningeal artery embolization), or surgical (bedside drain, burr-hole irrigation, and craniotomy) choices. [2][3][4][5][6][7][8][9][10][11][12][13] Current management is usually prescribed for an older patient usually on anticoagulant/antiplatelet medications with a high frailty index. One crucial question is how to select candidates for burr-hole surgery.…”