- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07751887
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma (EMMA-CS)
3. august 2026 opdateret af: University Hospital Hradec Kralove
Prospective Multicentric Study of Middle Meningeal Artery Embolisation Combined With Surgical Treatment for Chronic Subdural Hematoma
This international multicenter study evaluates the efficacy and safety of middle meningeal artery embolization (MMAE) using PVA particles or liquid embolic agents as a perioperative treatment to prevent the recurrence of chronic subdural hematoma (cSDH).
All participating patients across centers in the Czech Republic and Slovakia will receive the minimally invasive MMAE procedure within 7 days prior to or after surgical evacuation, with the primary goal of assessing hematoma recurrence rates and procedure-related complications over a 90-day follow-up period.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hradec Králové, Tjekkiet, 500 05
- University Hospital Hradec Kralove
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of a symptomatic or asymptomatic chronic or subacute subdural hematoma (cSDH) confirmed by neuroimaging (CT or MRI).
- Hematoma thickness of 5 mm or greater at its widest point on baseline neuroimaging.
- Patient is managed either conservatively or via standard surgical evacuation (e.g., burr-hole craniostomy) where MMAE is planned as a standalone or adjunctive treatment.
- Written informed consent provided by the patient or a legally authorized representative.
Exclusion Criteria:
- Acute subdural hematoma requiring emergency surgical decompression due to severe neurological deficit with signs of impending herniation.
- Evidence of an active intracranial infection or sepsis.
- Known vascular malformation, aneurysm, or dural arteriovenous fistula as the source of the hematoma.
- Severe uncorrectable coagulopathy or bleeding disorder (e.g., platelet count <50,000/µL or INR >2.0 that cannot be safely corrected before the procedure).
- Severe renal impairment (e.g., eGFR <30 mL/min/1.73m²) or known severe allergy to iodinated contrast media (unless adequate premedication is possible).
- Life expectancy of less than 3 months due to severe comorbid conditions.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention Arm
Patients with chronic subdural hematoma (cSDH) who undergo middle meningeal artery embolization (MMAE).
This procedure is performed either as a standalone treatment or as an adjunct to surgical evacuation, based on clinical indication.
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Endovascular occlusion of the middle meningeal artery (MMA) performed under fluoroscopic guidance.
The procedure aims to devascularize the chronic subdural hematoma membrane to promote hematoma resorption and prevent recurrence.
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Ingen indgriben: Standard Care Arm
Patients with chronic subdural hematoma (cSDH) who receive standard clinical care without undergoing middle meningeal artery embolization.
This includes standard surgical evacuation (burr-hole craniostomy) or conservative management (observation, medication) based on current guidelines.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of hematoma recurrence or treatment failure requiring surgical evacuation
Tidsramme: Up to 90 days post-enrollment.
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The proportion of participants who experience a symptomatic or radiologically confirmed recurrence or progression of chronic subdural hematoma (cSDH) in the target hemisphere that requires surgical intervention (or re-operation for surgically treated patients) within the follow-up period.
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Up to 90 days post-enrollment.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of periprocedural and postprocedural complications
Tidsramme: During hospitalization, up to 7 days post-procedure
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Safety outcomes evaluating complications related to the middle meningeal artery embolisation (MMAE) procedure or the embolic material.
This includes technical failure, ischemic stroke, new intracranial hemorrhage, facial nerve palsy, visual impairment, local arterial access site complications (e.g., hematoma, pseudoaneurysm), or severe allergic reactions to contrast media.
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During hospitalization, up to 7 days post-procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Siddiq F, Shakir M, Nguyen TN, Hassan AE, Abdalkader M, Kenmuir CL, Liebeskind DS, Novakovic R, Majidi S, Sheth SA, El-Ghanem M, Ortega-Gutierrez S, Guerrero WR, Malik AM. Consensus Statement on Middle Meningeal Artery Embolization in Chronic Subdural Hematoma Treatment: A Guideline from the Society of Vascular and Interventional Neurology Guidelines and Practice Standards Committee. Stroke Vasc Interv Neurol. 2025 Sep 15;5(6):e001814. doi: 10.1161/SVIN.125.001814. eCollection 2025 Nov.
- Mascitelli JR, Bulsara KR, Marden FA, Raper DMS, Tenser MS, Al Saiegh F, Waldau B, Hetts SW, Schirmer CM. Current state of the field and recommendations for middle meningeal artery embolization in chronic subdural hematoma: A Report of the SNIS Standards and Guidelines Committee, Endorsed by ANZSNR and ESMINT. J Neurointerv Surg. 2026 Apr 29:jnis-2026-024979. doi: 10.1136/jnis-2026-024979. Online ahead of print.
- Maresca G, Ottaviani M, Ryan KM, Brutti S, Appetecchi GB. Improved Compatibility of alpha-NaMnO2 Cathodes at the Interface with Ionic Liquid Electrolytes. ChemSusChem. 2024 Nov 11;17(21):e202400514. doi: 10.1002/cssc.202400514. Epub 2024 Jun 10.
- Brunet-Manquat L, Combedazou A, Ahuja B, Maden A, Ramus C, Mardovina T, Frolet C. Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug-device combination products: case study of a formative Comparative Use Human Factors study. Expert Opin Drug Deliv. 2024 May;21(5):767-778. doi: 10.1080/17425247.2024.2356678. Epub 2024 May 29.
- Peng MY, Zhang X, Li QD, Feng EM, Chen L, Yang HC, Guo B, Di YT, Tang L, Luo RC, Yan Y. Two new jatrophane diterpenoids from Euphorbia helioscopia with activity towards autophagic flux. J Asian Nat Prod Res. 2024 Aug;26(8):900-909. doi: 10.1080/10286020.2024.2345181. Epub 2024 May 16.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2026
Primær færdiggørelse (Anslået)
1. april 2029
Studieafslutning (Anslået)
1. juni 2029
Datoer for studieregistrering
Først indsendt
3. august 2026
Først indsendt, der opfyldte QC-kriterier
3. august 2026
Først opslået (Faktiske)
7. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. august 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Sår og skader
- Patologiske processer
- Kronisk sygdom
- Sygdomsegenskaber
- Blødning
- Kraniocerebralt traume
- Traumer, nervesystemet
- Intrakranielle blødninger
- Intrakraniel blødning, traumatisk
- Patologiske tilstande, tegn og symptomer
- Hæmatom, subdural
- Hæmatom
- Hæmatom, subdural, kronisk
Andre undersøgelses-id-numre
- FN HK
- Internal academic grant (Anden identifikator: University Hospital Hradec Kralove, Czech Republic)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data (IPD) including baseline demographics, clinical characteristics, neuroimaging metrics (hematoma thickness and volume), procedural details of middle meningeal artery embolisation, and follow-up clinical and radiological outcomes will be shared.
Only data that underlie the results reported in the final published article will be made available.
IPD-delingstidsramme
Data will become available beginning 6 months after the primary publication of the study results and will remain accessible for 36 months following publication.
IPD-delingsadgangskriterier
Anonymized data will be shared with qualified academic researchers upon reasonable request.
Requests must include a scientifically sound research proposal and a statistical analysis plan.
Proposals will be reviewed and approved by the principal investigators of the study.
Data will be shared strictly for the purpose of meta-analysis or independent verification of the results via secure data transfer.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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