Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma (EMMA-CS)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: David Brustman
- 전화번호: +420723419588
- 이메일: david.brustman@fnhk.cz
연구 연락처 백업
- 이름: Jan Raupach
- 이메일: jan.raupach@fnhk.cz
연구 장소
-
-
-
Hradec Králové, 체코, 500 05
- 모병
- University Hospital Hradec Kralove
-
연락하다:
- Johana Krempova
- 전화번호: +420601087319
- 이메일: davidbrustman@gmail.com
-
Liberec, 체코
- 모병
- Hospital Liberec
-
연락하다:
- Barbora Musilova
- 전화번호: +420485 311 111
- 이메일: barbora.musilova@nemlib.cz
-
연락하다:
- Miroslav Sercl
-
Olomouc, 체코, 77909
- 모병
- University Hospital Olomouc
-
연락하다:
- Tomas Malenak
- 전화번호: +420585 851 111
- 이메일: tomas.malenak@fnol.cz
-
연락하다:
- David Krieg
- 이메일: david.krieg@fnol.cz
-
Prague, 체코, 16902
- 모병
- The Military University Hospital Prague
-
연락하다:
- Richard Voldrich
- 전화번호: +420973 208 333
- 이메일: richard.voldrich@uvn.cz
-
Prague, 체코
- 모병
- University Hospital Motol and Homolka
-
연락하다:
- Radek Padr
- 전화번호: +420 224 431 111
- 이메일: radek.padr@fnmotol.cz
-
연락하다:
- Alena Snajdrova
- 이메일: alena.snajdrova@homolka.cz
-
České Budějovice, 체코
- 모병
- Hospital Ceske Budejovice
-
연락하다:
- Roman Klus
- 전화번호: +420387 871 111
- 이메일: klus.roman@nemcb.cz
-
연락하다:
- David Mestan
- 이메일: mestan.david@nemcb.cz
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
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. |
|
간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of hematoma recurrence or treatment failure requiring surgical evacuation
기간: Up to 90 days post-enrollment.
|
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. |
Up to 90 days post-enrollment.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of periprocedural and postprocedural complications
기간: During hospitalization, up to 7 days post-procedure
|
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. |
During hospitalization, up to 7 days post-procedure
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FN HK
- Internal academic grant (기타 식별자: University Hospital Hradec Kralove, Czech Republic)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .