| 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 |
| Authors: |
Shotar, Eimad; Mathon, Bertrand; Rouchaud, Aymeric; Mounayer, Charbel; Salle, Henri; Bricout, Nicolas; Lejeune, Jean-Paul; Janot, Kevin; Zemmoura, Ilyess; Naggara, Olivier; Roux, Alexandre; Goutagny, Stéphane; Guedon, Alexis; Brunel, Herve; Troude, Lucas; Dufour, Henry; Bernat, Anne-Laure; Tuilier, Titien; Bresson, Damien; Apra, Caroline; Fouet, Mathilde; Escalard, Simon; Chauvet, Dorian; Baptiste, Amandine; Lebbah, Said; Dechartres, Agnès; Clarençon, Frédéric |
| Contributors: |
CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Sorbonne Université (SU); CHU Limoges; BIO-SANTÉ (XLIM-BIO-SANTÉ); XLIM (XLIM); Université de Limoges (UNILIM)-Centre National de la Recherche Scientifique (CNRS)-Université de Limoges (UNILIM)-Centre National de la Recherche Scientifique (CNRS); Service de Neurochirurgie CHU Limoges; Contrôle de l’Activation Cellulaire, Progression Tumorale et Résistance thérapeutique (CAPTuR); Institut National de la Santé et de la Recherche Médicale (INSERM)-OmégaHealth (ΩHealth); Université de Limoges (UNILIM)-Université de Limoges (UNILIM); Université de Lille; Thérapies Assistées par Lasers et Immunothérapies pour l'Oncologie - U 1189 (OncoThAI); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Service de neuroradiologie CHRU Tours; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Service de Neurochirurgie CHRU de Tours; Service de neuroradiologie Paris; Hôpital Sainte-Anne; Groupe hospitalier universitaire Paris psychiatrie & neurosciences Paris (GHU Paris Psychiatrie et Neurosciences); Hôpital Beaujon AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S 1144 / U1144)); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité); Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP); Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU); Assistance Publique - Hôpitaux de Marseille (APHM); Aix-Marseille Université - Faculté de médecine (AMU MED); Aix Marseille Université (AMU); Hôpital Nord CHU - APHM; Marseille medical genetics - Centre de génétique médicale de Marseille (MMG); Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM); Institut Marseille Maladies Rares (MarMaRa); Service de neurochirurgie CHU Marseille; Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Timone CHU - APHM (TIMONE); CHU Henri Mondor Créteil; Groupe Henri Mondor-Albert Chenevier-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Institut Mondor de Recherche Biomédicale (IMRB); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12); Université Paris Descartes - Faculté de Médecine (UPD5 Médecine); Université Paris Descartes - Paris 5 (UPD5); École du Val de Grâce (EVDG); Service de Santé des Armées; Hôpital d'instruction des Armées Percy; Fondation Ophtalmologique Adolphe de Rothschild Paris; Fondation Ophtalmologique Adolphe de Rotschild; Pharmacoépidémiologie et évaluation des soins iPLesp (PEPITES); Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU); The study was 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. |
| Source: |
ISSN: 1759-8478. |
| Publisher Information: |
CCSD; BMJ Journals |
| Publication Year: |
2024 |
| Subject Terms: |
[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]; [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery; [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie |
| Description: |
International audience ; 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 . |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1136/jnis-2023-021249 |
| Availability: |
https://hal.science/hal-04648337; https://hal.science/hal-04648337v1/document; https://hal.science/hal-04648337v1/file/JNIS2024Shotaretal.Embolization%202025.pdf; https://doi.org/10.1136/jnis-2023-021249 |
| Rights: |
https://about.hal.science/hal-authorisation-v1/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.2F9B99DD |
| Database: |
BASE |