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Dexamethasone not indicated for chronic subdural haematoma

Presented by
Dr Ishita Miah, Leiden University Medical Center, the Netherlands
Conference
EAN 2021
Trial
Phase 4, DECSA
Results of the DECSA trial demonstrated that dexamethasone is not indicated for the treatment of symptomatic chronic subdural haematoma; surgery is the appropriate treatment. In the trial, both treatments were directly compared.

The incidence of chronic subdural haematoma is rising due to the ageing population and the increasing use of oral anticoagulant therapy. Surgery by burr hole craniotomy with closed subdural drainage is still the mainstay of therapy, but dexamethasone is widely applied as an alternative or adjuvant treatment.

The DECSA trial (EUCTR 2015-001563-39) tested the hypothesis that dexamethasone is non-inferior to surgical treatment in achieving favourable functional outcome [1]. DECSA was a randomised, multicentre, phase 4 trial with blinded endpoint assessment. Patients with chronic subdural haematoma were allocated to dexamethasone 16 mg daily for 4 days, then tapered to 50% every 3 days over 19 days; or surgery by burr hole craniotomy with closed subdural drainage within 24–48 hours. Primary endpoints were favourable functional outcome at 3 months (modified Rankin Scale score 0–2) and, in a separate study, cost-effectiveness at 12 months. Results were presented by Dr Ishita Miah (Leiden University Medical Center, the Netherlands).

An interim-analysis including 252 participants revealed between-group differences in efficacy and safety, after which immediate termination of the trial was recommended. Favourable functional outcome was seen in 79 of 124 patients (63.7%) in the dexamethasone group versus in 97 of 124 patients (78.2%) in the surgery group (adjusted OR 0.70; 95% CI 0.33–2.95). No symptoms were observed in 21 of 124 patients (16.9%) versus 44 of 124 patients (35.5%), respectively. Eight (6.5%) versus 2 patients (1.6%) died (adjusted OR 2.74; 95% CI 0.45–16.65). The number of patients with serious adverse events was 61 (65.6%) versus 32 (34.4%), respectively. In the dexamethasone group, 67 of 127 (52.8%) needed additional surgery.

  1. Miah IP, et al. Dexamethasone versus Surgical Treatment for Chronic Subdural Hematoma: The DECSA trial. OPR-202, EAN 2021 Virtual Congress, 19–22 June.

 

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