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Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).
Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear. Case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. Risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials.
The benefit of the embolization is a substantial reduction in recurrence of cSDH, which has been reported to be as high 1 in 3-4 patients. Recurrence of cSDH can lead to additional surgery and complications.
First objective: Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments (Arm 2) versus surgery alone (Arms 1).
Second objective: The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Surgery - No embolization (control) | No Intervention | Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management. | |
| Arm 2 - Surgery - MMA embolisation | Experimental | Patients who undergo surgical treatment will be randomized into receiving embolization within 72 hours post-surgery (Arm 2) or no-embolization post-surgery (conventional management, Arm 1). Patients will be randomized at rate of 2 MMA embolization to 1 conventional management. |
|
| Arm 3 - No surgery - Embolization accepted | Active Comparator | Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization accepted : Arm 3. |
|
| Arm 4 - No surgery - Embolization not accepted | No Intervention | Patients who are excluded for surgery due to significant medical contraindications or patients who refuse surgery, will be considered for embolization only. Embolization refused : Arm 4. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMA embolization | Radiation | Middle meningeal artery embolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of cSDH - 1 | Surgical reoperation | 6-months |
| Recurrence of cSDH - 2 | Neurological deterioration due to a cSDH after evacuation | 6-months |
| Recurrence of cSDH - 3 | Post-operative hematoma volume of more than 90% of the preoperative volume at follow-up | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Additional clinical outcomes - 1 | Glasgow Coma Scale (Min=3; Max=15; Higher score=Best outcome) | 6-months |
| Additional clinical outcomes - 2 | modified Ranking Scale (Min=0; Max=6; Higher score=Worse outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aria Nouri | Contact | +41795530958 | aria.nouri@hug.ch |
| Name | Affiliation | Role |
|---|---|---|
| Aria Nouri | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40335147 | Derived | Al Awadhi A, Mollica C, Da Broi M, Molliqaj G, Hofmeister J, Rosi A, Bernava G, Machi P, Morel S, Cardia A, Meling TR, Schaller K, Nouri A. Middle meningeal artery (MMA) embolisation for chronic subdural haematomas: rationale and design for the STOp Recurrence of MMA Bleeding (STORMM) randomised control trial-a study protocol. BMJ Open. 2025 May 6;15(5):e092014. doi: 10.1136/bmjopen-2024-092014. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2024 | Mar 4, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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This study is a multicentre randomised-controlled trial.
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| 6-months |
| Additional clinical outcomes - 3 | Markwalder Grading Scale (Min=0; Max=4; Higher score=Worse outcome) | 6-months |
| Additional clinical outcomes - 4 | Glasgow Outcome Scale - Extended (Min=1; Max=8; Higher score=Best outcome) | 6-months |
| Additional clinical outcomes - 5 | Karnofsky Performance Score (Min=20; Max=100; Higher score=Best outcome) | 6-months |
| Additional clinical outcomes - 6 | Therapy-Disability-Neurology grading system (Min=1; Max=5; Higher score=Worse outcome) | 6-months |
| Additional clinical outcomes - 7 | Mortality rate | 6-months |
| Additional clinical outcomes - 8 | Re-hospitalisation for all causes | 6-months |
| EOC | Recruiting | Lugano | Switzerland |
|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |