Journal Article

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

Escalard, Simon, Jaoude, Samiya Abi, Lenck, Stéphanie, Boissonneau, Sébastien, Aboukais, Rabih, Janot, Kevin, Bricout, Nicolas, Salle, Henri, Dufour, Henry, Naggara, Olivier, Bernat, Anne-Laure, Tuilier, Titien, Faillot, Mathieu, Sourour, Nader-Antoine, Labeyrie, Marc Antoine, Delmas, Jean Marc, Desilles, Jean Philippe, Houdart, Emmanuel, Marchal, Adrien, Maurice, Jean Pierre Saint, Gueye, Edouard, Delvoye, François, Kalsoum, Erwa, Lejeune, Jean-Paul, Lefevre, Etienne, Iakovlec, Gueorgui, Meyer, Mikael, Hak, Jean François, Forestier, Géraud, Rodriguez, Christine, Brunel, Herve, Pechi-Florianu, Iulia, Piotin, Michel, Amelot, Aymeric, Bresson, Damien, Chauvet, Dorian, Civelli, Vittorio, Avinens, Valentin, Clarençon, Frédéric, Bala, Fouzi, Reyre, Anthony, Gortais, Hugo, Carle, Adrien Ortiz, Rouchaud, Aymeric, Obled, Louis, Abbritti, Rosaria, Allard, Julien, Bretzner, Martin, Legrand, Victor, Elhorany, Mahmoud, Karnoub, Mélodie-Anne, Boulouis, Grégoire, Mathon, Bertrand, Chiaroni, Pierre-Marie, Bocco, Alberic, Roux, Alexandre, Terrier, Louise Marie, Kaissar, Farah, Marijon, Pauline, Saleme, Suzana, Troude,

2025

Overview

BackgroundMiddle 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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 numberNCT04372147.

• Publisher: BMJ Publishing Group Ltd,BMJ Publishing Group LTD,BMJ Journals,BMJ Publishing Group
• Subject: Anticoagulants / Clinical trials / Embolic / Embolization / Embolization, Therapeutic / Embolization, Therapeutic - methods / General anesthesia / Hematoma / Hematoma, Subdural, Chronic / Hematoma, Subdural, Chronic - surgery / Hemorrhage / Human health and pathology / Human health sciences / Humans / Informed consent / Life expectancy / Life Sciences / Local anesthesia / Medical imaging / Meningeal Arteries / Meningeal Arteries - diagnostic imaging / Meningeal Arteries - surgery / Mortality / Neurologie / Neurology / Neurology (clinical) / Neurons and Cognition / New devices and techniques / Patients / Recurrence / Risk factors / Santé publique et épidémiologie / Sciences de la santé humaine / Secondary Prevention / Secondary Prevention - methods / Standard of care / Subdural / Surgery / Treatment Outcome / Veins & arteries