Corticosteroids as an Adjuvant Treatment to Surgery in Chronic Subdural Hematomas: A Multi-Center Double-Blind Randomized Placebo-Controlled Trial - Aix-Marseille Université Accéder directement au contenu
Article Dans Une Revue Journal of Neurotrauma Année : 2021

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

Sam Ng
Pascal Sabatier
  • Fonction : Auteur
Emilie Aloy
  • Fonction : Auteur
Guillaume Boniface
  • Fonction : Auteur
Emilie Chan-Seng
  • Fonction : Auteur
Jérôme Cochereau
  • Fonction : Auteur
Henry Dufour
  • Fonction : Auteur
Kaissar Farah
  • Fonction : Auteur
Denis Fontaine
  • Fonction : Auteur
Thomas Graillon
  • Fonction : Auteur
Guillaume Gras-Combe
  • Fonction : Auteur
Vanessa Gros
  • Fonction : Auteur
William Haynes
  • Fonction : Auteur
Kifah Khouri
  • Fonction : Auteur
Marine Le Corre
  • Fonction : Auteur
André Maillard
  • Fonction : Auteur
Philippe Paquis
  • Fonction : Auteur
Gaëtan Poulen
  • Fonction : Auteur
Adeline Quintard
  • Fonction : Auteur
Marie-Ange Rodriguez
  • Fonction : Auteur
Alice Rolland
  • Fonction : Auteur
Maxime Ros
  • Fonction : Auteur
François Segnarbieux
  • Fonction : Auteur
Nizar Suleiman
  • Fonction : Auteur
Lucas Troude
Matthieu Vassal
  • Fonction : Auteur
Anne-Sophie Verissimo
  • Fonction : Auteur

Résumé

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.
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Dates et versions

hal-03574895 , version 1 (04-05-2022)

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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⟩
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