Steroid for chronic subdural hematoma? A prospective phase IIB pilot randomized controlled trial on the use of dexamethasone with surgical drainage for the reduction of recurrence with reoperation

Abstract

Background: Chronic subdural hematoma is a common neurosurgical condition especially in the aging population. Burr hole for drainage is an effective treatment, yet recurrence is reported at 8 to 22 % worldwide, and 1-year mortality rates could be as high as 32 %. Our previous study on the use of dexamethasone as a primary nonsurgical treatment showed good response in selected group of patients. This study aims to assess the efficacy of dexamethasone with surgical drainage in the reduction of recurrence requiring reoperation. Methods: From October 2000 to September 2006, patients with chronic subdural hematoma admitted to the Prince of Wales Hospital, The Chinese University of Hong Kong, were randomized to surgical drainage with steroid versus surgical drainage only. The primary endpoint was symptomatic recurrence requiring reoperation. Results: Two hundred forty-eight patients were recruited and consented for the randomization during the study period. One hundred twenty-two received both surgery and steroid (the intervention arm) while 126 received surgery only (the control arm). The recurrence rate requiring reoperation was 6.6 % (8/122) and 13.5 % (17/126), respectively (p = 0.109). There was no significant difference in complications such as chest infection (p = 0.201) or wound infection (p = 0.987). Favorable outcome (Glasgow Outcome Score 4-5) was 104/122 (85.2 %) in the intervention group versus 105/126 (83.3 %) in the control group, respectively (p = 0.811). Based on the recurrence rate in our study, we generate a potential sample size of at least 594 patients (type I error = 5 %, power = 80 %, two-sided test) to detect a significant difference. Conclusions, brief summary, and potential implications: In this prospective pilot phase IIB randomized controlled study, steroid with surgical drainage had a lower recurrence with reoperation though statistically insignificant. It was safe with no significant difference in complication rates. This pilot study generates a potential sample size for a definitive larger double-blinded randomized controlled trial in the future.

The use of atorvastatin for chronic subdural haematoma: a retrospective cohort comparison study

“…7 The underlying pathogenesis was postulated to be pathological aberrant vessel formation 8 and localised inflammation. 9,10,11 This formed the pathophysiological basis of the use of steroid for CSDH 12,13 and its potential role as a primary non-surgical treatment of CSDH in selected groups of patients. 14 The formation of these immature vessels at the neomembrane was hypothesised to contribute to plasma extravasation and haematoma progression.…”

Chronic subdural haematoma during the COVID-19 lockdown period: late presentation with a longer interval from the initial head injury to the final presentation and diagnosis

“…cSDH can be associated with minor head injuries [4]. In those who can recall a history of head injury, the timing of the injury was usually around 4 weeks before the CSDH was developed and diagnosed and it ranges from 2 to 6 weeks [5][6][7][8][9]. The time frame can even be shorter for those who were on antiplatelets or anticoagulants [10][11][12].…”

Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase

“…Recurrence 4% with dex versus 15% without.Delgado-Lopez(2009) 9 101(median 6 M)12 mg daily, tapering by 1 mg every 3 days( 46 . 8 mg )Hyperglycaemia (14.8%) and infections (9%), 1 gastric ulcer (<1%).78.2% dex patients avoided surgery.96% favourable outcome with dex.Berghauser Pont(2012) 4 496(3 M)dex 16 mg daily starting median of 4 days pre-op and then weaning( unspecified ).Empyema 2.8%DVT/PE 1.8%Hyperglycaemia only whilst on dex.Longer pre-operative dex dose associated with lower recurrence and noincreased morbidity.Berghauser Pont (2012) 5 5 studies with total 520 Study 1–3 as per Bender, Delgado-Lopez, Sun 2,7,8 Study 4: 16 mg/day tapering over 8wks.Study 5: 0.5 mg/kg pred = 6 mg dex/day for 4 wks.Infections 9%GI bleed <1% (2/520)Hyperglycaemia 7.7–14.8% (higher with long-term use)Good outcome in 83–100% with steroids and64–92% surgery alone Recurrence: 4–27.8% with steroids and 15–26.3% surgery alone.Emich(2014) 52 820 dex and placebo(24 weeks)6 day course of dex from 16 mg/day to, 4 mg/day.( 68 mg )Trial on-going since 2014: no safety issues reportedPrimary end-point will be re-operation within 12 weeks.Chan(2015) 53 122 dex & surgery126 surgery alone16 mg for 4D, 6 mg for 3D, 2 mg for 3D( 61 . 6 mg ).No increase in adverse events with dex6.6% recurrence dex & surgery, 13.5% surgery only.…”