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.
Embolic
Hemorrhage
Subdural
Journal
Journal of neurointerventional surgery
ISSN: 1759-8486
Titre abrégé: J Neurointerv Surg
Pays: England
ID NLM: 101517079
Informations de publication
Date de publication:
02 Feb 2024
02 Feb 2024
Historique:
received:
13
11
2023
accepted:
10
01
2024
medline:
3
2
2024
pubmed:
3
2
2024
entrez:
2
2
2024
Statut:
aheadofprint
Résumé
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. 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. 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. 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. NCT04372147.
Sections du résumé
BACKGROUND
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
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
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
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
BACKGROUND
NCT04372147.
Identifiants
pubmed: 38307722
pii: jnis-2023-021249
doi: 10.1136/jnis-2023-021249
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04372147']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Nader-Antoine Sourour
(NA)
Kevin Premat
(K)
Stéphanie Lenck
(S)
Julien Allard
(J)
Pierre-Marie Chiaroni
(PM)
Mahmoud Elhorany
(M)
Anne Sophie Montero
(AS)
Etienne Lefevre
(E)
Alexandre Carpentier
(A)
Maximilien Riche
(M)
Pauline Marijon
(P)
Vincent Reina
(V)
Henri Malaize
(H)
Wagih Ben Hassen
(WB)
Denis Trystram
(D)
Basile Kerleroux
(B)
Hugo Gortais
(H)
Christine Rodriguez
(C)
Alexandre Roux
(A)
Chiara Benevello
(C)
Emmanuel Houdart
(E)
Jean Pierre Saint Maurice
(JPS)
Vittorio Civelli
(V)
Nader-Antoine Sourour
(NA)
Kevin Premat
(K)
Stéphanie Lenck
(S)
Julien Allard
(J)
Pierre-Marie Chiaroni
(PM)
Mahmoud Elhorany
(M)
Anne Sophie Montero
(AS)
Etienne Lefevre
(E)
Alexandre Carpentier
(A)
Maximilien Riche
(M)
Pauline Marijon
(P)
Vincent Reina
(V)
Henri Malaize
(H)
Wagih Ben Hassen
(WB)
Denis Trystram
(D)
Basile Kerleroux
(B)
Hugo Gortais
(H)
Christine Rodriguez
(C)
Alexandre Roux
(A)
Chiara Benevello
(C)
Emmanuel Houdart
(E)
Jean Pierre Saint Maurice
(JPS)
Vittorio Civelli
(V)
Marc Antoine Labeyrie
(MA)
Mathilde Aubertin
(M)
Rosaria Abbritti
(R)
Gueorgui Iakovlec
(G)
Mathieu Faillot
(M)
Helene Staquet
(H)
Adrien Ortiz Carle
(AO)
Alberic Bocco
(A)
Feras Farhat
(F)
Erwa Kalsoum
(E)
Rodrigue Jayr
(R)
Michel Piotin
(M)
Raphael Blanc
(R)
William Boisseau
(W)
François Delvoye
(F)
Quentin Holay
(Q)
Jean Philippe Desilles
(JP)
Hocine Redjem
(H)
Stanislas Smajda
(S)
Amira Al-Raasi
(A)
Dorian Chauvet
(D)
Samiya Abi Jaoude
(SA)
Jean Marc Delmas
(JM)
François-Léopold Maison
(FL)
Suzana Saleme
(S)
Géraud Forestier
(G)
Clément Gantois
(C)
Leslie Lemnos
(L)
Edouard Gueye
(E)
Jean François Hak
(JF)
Anthony Reyre
(A)
Sébastien Boissonneau
(S)
Thomas Graillon
(T)
Farah Kaissar
(F)
Mikael Meyer
(M)
Adamou Touta
(A)
Guillaume Baucher
(G)
Valentin Avinens
(V)
Thomas Personnic
(T)
Adrien Marchal
(A)
Martin Bretzner
(M)
Lucas Grenier
(L)
Mélodie-Anne Karnoub
(MA)
Victor Legrand
(V)
Henri-Arthur Leroy
(HA)
Bastier Gouges
(B)
Amelie Toubol
(A)
Antoine Devalckeneer
(A)
Louis Obled
(L)
Rabih Aboukais
(R)
Iulia Pechi-Florianu
(I)
Grégoire Boulouis
(G)
Héloise Ifergan
(H)
Fouzi Bala
(F)
Aymeric Amelot
(A)
Louise Marie Terrier
(LM)
Informations de copyright
© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
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.