Embolization of the middle meningeal artery for the prevention of chronic subdural hematoma recurrence in high-risk patients: a randomized controlled trial-the EMPROTECT study protocol.
[en] [en] BACKGROUND: Middle meningeal artery (MMA) embolization has been proposed as a treatment of chronic subdural hematoma (CSDH). The benefit of the procedure has yet to be demonstrated in a randomized controlled trial. We aim to assess the efficacy of MMA embolization in reducing the risk of CSDH recurrence 6 months after burr-hole surgery compared with standard medical treatment in patients at high risk of postoperative recurrence.
METHODS: The EMPROTECT trial is a multicenter open label randomized controlled trial (RCT) involving 12 French centers. Adult patients (≥18 years) operated for CSDH recurrence or for a first episode with a predefined recurrence risk factor are randomized 1:1 to receive either MMA embolization within 7 days of the burr-hole surgery (experimental group) or standard medical care (control group). The number of patients to be included is 342.
RESULTS: The primary outcome is the rate of CSDH recurrence at 6 months. Secondary outcomes include the rate of repeated surgery for a homolateral CSDH recurrence during the 6-month follow-up period, the rate of disability and dependency at 1 and 6 months, defined by a modified Rankin Scale (mRS) score ≥4, mortality at 1 and 6 months, total cumulative duration of hospital stay during the 6-month follow-up period, directly or indirectly related to the CSDH and embolization procedure-related complication rates.
CONCLUSIONS: The EMPROTECT trial is the first RCT evaluating the benefit of MMA embolization as a surgical adjunct for the prevention of CSDH recurrence. If positive, this trial will have a significant impact on patient care.
TRIAL REGISTRATION NUMBER: NCT04372147.
Disciplines :
Neurology
Author, co-author :
Shotar, Eimad; Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France eimad.shotar@aphp.fr ; Sorbonne Université, INSERM, Institut de la Vision, Paris, France
Mathon, Bertrand ; Neurosurgery, Pitié-Salpêtrière Hospital, Paris, France ; Sorbonne Université, Paris, France
Rouchaud, Aymeric ; Interventional Neuroradiology, Centre Hospitalier Universitaire de Limoges, Limoges, France ; University of Limoges, CNRS, XLIM, UMR 7252, Limoges, France
Mounayer, Charbel; Interventional Neuroradiology, Centre Hospitalier Universitaire de Limoges, Limoges, France ; University of Limoges, CNRS, XLIM, UMR 7252, Limoges, France
Salle, Henri ; Neurosurgery, CHU Limoges, Limoges, France
Bricout, Nicolas; Interventional Neuroradiology, Centre Hospitalier Regional Universitaire de Lille, Lille, Hauts-de-France, France
Lejeune, Jean-Paul; Neurosurgery, Lille University Hospital, Lille, France
Janot, Kevin ; Neuroradiology, University Hospital of Tours, Tours, France
Zemmoura, Ilyess; Department of Neursurgery, Tours University Hospital, Tours, France
Naggara, Olivier; Department of Neuroradiology, Hospital Saint Anne, Paris, France
Roux, Alexandre; Department of Neursurgery, Sainte Anne Hospital, Paris, France
Goutagny, Stéphane; Department of Neursurgery, Beaujon Hospital, Clichy, France
Guedon, Alexis ; Neuroradiology, Lariboisière Hospital, Paris, France
Brunel, Herve; Neuroradiology, La Timone Hospital, Paris, France
Troude, Lucas; Department of Neursurgery, Hopital Nord, Marseille, France
Dufour, Henry; Department of Neursurgery, La Timone Hospital, Marseille, France
Bernat, Anne-Laure; Neurosurgery, Groupe hospitalier Lariboisiere Fernand-Widal, Paris, Île-de-France, France
Tuilier, Titien; Neuroradiology, Henri Mondor University Hospital, Creteil, France
Bresson, Damien; Neurosurgery, Foch Hospital, Suresne, France
Apra, Caroline; Department of Neursurgery, Henri-Mondor Hospital, Créteil, France
Fouet, Mathilde; Department of Neursurgery, Percy Military Teaching Hospital, Clamart, France
Escalard, Simon; Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France
Chauvet, Dorian; Neurosurgery, Fondation Ophtalmologique Adolphe de Rothschild, Paris, Île-de-France, France
Baptiste, Amandine; Unité de Recherche Clinique, Pitié-Salpêtrière Hospital, Paris, France
Lebbah, Said; Unité de Recherche Clinique, Pitié-Salpêtrière Hospital, Paris, France
Dechartres, Agnès; Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, Département de Santé Publique, Paris, France
Clarençon, Frédéric; Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France ; Sorbonne Université, Paris, France
Delvoye, François ; Université de Liège - ULiège > Département des sciences cliniques
Language :
English
Title :
Embolization of the middle meningeal artery for the prevention of chronic subdural hematoma recurrence in high-risk patients: a randomized controlled trial-the EMPROTECT study protocol.
The study is funded by a grant from Programme Hospitalier de Recherche Clinique - PHRC 2018 (Ministère de la Santé); PHRC-IR AOR18104. Several devices (embolization particles, coils and coiling microcatheters) are provided free of charge by industry laboratories (Merit Medical, Balt). Terumo corporation also provided a discount on the price of Progreat microcatheters. None of the institutional or corporate funders of the trial were or will be involved in the study design, data analysis, interpretation of results, or writing and reviewing of the trial results publication. There are no publication restrictions in the trial protocol.
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