Corticosteroids as an adjuvant treatment to Surgery in Chronic Subdural Hematomas: a multicenter double-blind randomized placebo-controlled trial.

Abstract

Chronic subdural hematoma (CSDH) is a common condition requiring surgery; however, recurrence occurs in 15-25% of cases despite surgical management. The HEMACORT trial was a prospective randomized, double-blind, placebo-controlled, multicentric study (NCT01380028). The aim of this trial was to determine the effect of corticosteroids as an adjuvant treatment to surgery on CSDH recurrence at 6 months. After surgery, participants were assigned by block-randomization to receive either placebo or oral prednisone at a dose of 1mg/kg/day followed by weekly stepwise tapering in steps of 10 mg/day. The primary outcome was CSDH recurrence, defined by the need for reoperation and/or radiological progression of CSDH. Secondary outcomes were 1-year mortality, radiological changes, safety, neurological status and quality of life. The trial was discontinued at midpoint of expected inclusions: 78 participants received Prednisone and 77 received placebo controls. In an intention-to-treat analysis, CSDH clinico-radiological recurrence was not different between Prednisone and placebo groups (21.8% vs. 35.1%, respectively; Hazard-Ratio 0.56; 95%CI[0.30-1.02]; P=.06) although post-hoc analyses concluded to statistical significance (P=.02). Earlier radiological resolution was observed after Prednisone administration, but reoperation rates (reaching 5.8% overall) and functional outcomes were not different at 6 months. Among adverse events, sleep disorders occurred more often in the Prednisone group (26.1% vs 9.1%, P=.02). HEMACORT trial data suggest that prednisone, as an adjuvant treatment to surgery, may reduce early radiological recurrence of CSDH although clinical benefits are unclear. In view of these findings, the authors suggest that shorter treatment duration should be assessed for safety and efficacy in future trials.