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Abstract
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.
- Subdural
- Embolic
- Hemorrhage
Data availability statement
Data are available upon reasonable request by a researcher independent of the study. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not allow the transmission of the database, nor the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Data availability statement
Data are available upon reasonable request by a researcher independent of the study. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not allow the transmission of the database, nor the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Footnotes
Collaborators EMPROTECT collaboration: Dr Nader-Antoine Sourour, Dr Kevin Premat, Dr Stéphanie Lenck, Dr Julien Allard, Dr Pierre-Marie Chiaroni, Dr Mahmoud Elhorany, Dr Anne Sophie Montero, Dr Etienne Lefevre, Pr Alexandre Carpentier, Dr Maximilien Riche, Dr Pauline Marijon, Dr Vincent Reina, Dr Henri Malaize, Dr Wagih Ben Hassen, Dr Denis Trystram, Dr Basile Kerleroux, Dr Hugo Gortais, Dr Christine Rodriguez, Dr Alexandre Roux, Dr Chiara Benevello, Pr Emmanuel Houdart, Dr Jean Pierre Saint Maurice, Dr Vittorio Civelli, Dr Marc Antoine Labeyrie, Dr Mathilde Aubertin, Dr Rosaria Abbritti, Dr Gueorgui Iakovlec, Dr Mathieu Faillot, Dr Helene Staquet, Dr Adrien Ortiz Carle, Dr Alberic Bocco, Dr Feras Farhat, Dr Erwa Kalsoum, Dr Rodrigue Jayr, Dr Michel Piotin, Dr Raphael Blanc, Dr William Boisseau, Dr François Delvoye, Dr Quentin Holay, Dr Jean Philippe Desilles, Dr Hocine Redjem, Dr Stanislas Smajda, Dr Amira Al-Raasi, Dr Dorian Chauvet, Dr Samiya Abi Jaoude, Dr Jean Marc Delmas, Dr François-Léopold Maison, Dr Suzana Saleme, Dr Géraud Forestier, Dr Clément Gantois, Dr Leslie Lemnos, Dr Edouard Gueye, Dr Jean François Hak, Dr Anthony Reyre, Dr Sébastien Boissonneau, Dr Thomas Graillon, Dr Farah Kaissar, Dr Mikael Meyer, Dr Adamou Touta, Dr Guillaume Baucher, Dr Valentin Avinens, Dr Thomas Personnic, Dr Adrien Marchal, Dr Martin Bretzner, Dr Lucas Grenier, Dr Mélodie-Anne Karnoub, Dr Victor Legrand, Dr Henri-Arthur Leroy, Dr Bastier Gouges, Dr Amelie Toubol, Dr Antoine Devalckeneer, Dr Louis Obled, Dr Rabih Aboukais, Dr Iulia Pechi-Florianu, Dr Grégoire Boulouis, Dr Héloise Ifergan, Dr Fouzi Bala, Dr Aymeric Amelot, Dr Louise Marie Terrier.
Contributors Dr Eimad Shotar, MD is the trial coordinator: study design, study conduct, patient enrollment, data collection, drafting the manuscript, approving the final version of the manuscript and study guarantor. Ms Amandine Baptiste, MSc and Mr Said Lebbah, MSc are the trial statisticians: data analysis, reviewing the manuscript and approving the final version of the manuscript. Pr Frédéric Clarençon, MD, PhD is the trial scientific lead: study design, study supervision, study conduct, patient enrollment, data collection, reviewing the manuscript and approving the final version of the manuscript. Pr Agnès Dechartres, MD, PhD is the trial methodologist: study design, study supervision, data analysis, reviewing the manuscript and approving the final version of the manuscript. All other co-authors are trial investigators: patient enrollment, data collection, reviewing the manuscript and approving the final version of the manuscript.
Funding 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.
Competing interests Dr Sourour reports a conflict of interest with Medtronic, Balt Extrusion, Microvention (consultant). Prof Clarençon reports a conflict of interest with Medtronic, Balt Extrusion (consultant), ClinSearch (core lab), Penumbra, Stryker (payment for reading) and Artedrone (Board). The other authors report no conflicts of interest.
Provenance and peer review Not commissioned; externally peer reviewed.
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