Skip to Main content Skip to Navigation
New interface
Journal articles

Corticosteroids as an Adjuvant Treatment to Surgery in Chronic Subdural Hematomas: A Multi-Center Double-Blind Randomized Placebo-Controlled Trial

Abstract : Chronic subdural hematoma (CSDH) is a common condition necessitating surgery; however, recurrence occurs in 15–25% of cases despite surgical management. The HEMACORT trial was a prospective randomized, double-blind, placebo-controlled, multi-centric 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 1 mg/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 one-year death, 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 clinicoradiological recurrence was not different between prednisone and placebo groups (21.8% vs. 35.1%, respectively; hazard ratio 0.56; 95% confidence interval 0.30–1.02; p = 0.06), although post hoc analyses concluded to statistical significance (p = 0.02). 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 = 0.02). The 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.
Complete list of metadata

https://hal-amu.archives-ouvertes.fr/hal-03574895
Contributor : Guillaume Rao Connect in order to contact the contributor
Submitted on : Wednesday, May 4, 2022 - 10:41:59 AM
Last modification on : Wednesday, September 28, 2022 - 4:20:12 PM

Files

neu.2020.7560.pdf
Files produced by the author(s)

Identifiers

Collections

Citation

Sam Ng, Julien Boetto, Héléna Huguet, Pierre-Hugues Roche, Stéphane Fuentes, et al.. Corticosteroids as an Adjuvant Treatment to Surgery in Chronic Subdural Hematomas: A Multi-Center Double-Blind Randomized Placebo-Controlled Trial. Journal of Neurotrauma, 2021, 38 (11), pp.1484-1494. ⟨10.1089/neu.2020.7560⟩. ⟨hal-03574895⟩

Share

Metrics

Record views

56

Files downloads

56