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| Name | Class |
|---|---|
| Lund University | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Karolinska University Hospital | OTHER |
| Norrlands University Hospital |
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The SWEMMA trial is an open, national, multi-center, prospective, randomized (1:1), superiority trial designed to assess impact on reoperation rates for chronic subdural hematoma with a head-to-head comparison of embolization of the middle meningeal artery (intervention) with standard neurosurgical hematoma evacuation (control).
Introduction: Chronic subdural hematoma (CSDH) is one of the most common neurosurgical disorders and the incidence is rising. The mainstay of treatment is neurosurgical hematoma evacuation followed by postoperative drainage but recurrence and reoperation rates are as high as 10-30%. Embolization of the middle meningeal artery (EMMA) has been proposed as an adjunct or as sole therapy and initial data suggests markedly reduced reoperation rates. Several randomised trials are currently underway, mostly randomizing with EMMA as an adjunctive to evacuation, or as an alternative to conservative treatment. This trial aims to make a head-to-head comparison of neurosurgical evacuation versus EMMA.
Aims: The primary objective of the trial is to compare efficacy of EMMA on rates of reoperation by randomizing patients with CSDH and mild to moderate symptoms to either EMMA or standard neurosurgical evacuation. Secondary objectives include all complication rate, technical success rate, residual hematoma volume at 3 months, neurological functionality and quality of life at 3 and 12 months and composite endpoint of death or reoperation at 3 and 12 months.
Method: Patients with previously untreated CSDH admitted to the neurosurgical unit at participating centers with clinical and/or radiological indication for neurosurgical evacuation, mild to moderate symptoms and able to provide informed consent, will be randomized to either standard treatment or EMMA. Immediately after either procedure the participant returns to standard clinical care. At 3 months a CT of the head is performed. A structured telephone interview is held by a treatment-blinded outcomes assessor at 3 months and 12 months, measuring quality of life (EQ-5D) and neurological disability (mRS). Medical records are collected and assessed at 3 months regarding safety measures. Data on reoperation and mortality are collected from the National Board of Health and Welfare and National Cause of Death Registry at 3 months and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolization of middle meningeal artery | Experimental | Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s). |
|
| Standard neurosurgical hematoma evacuation and drainage | Active Comparator | Participants receive standard neurosurgical hematoma evacuation via burr hole or mini craniotomy and post-operative subdural or subgaleal drainage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment of the middle meningeal artery | Procedure | The middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents. |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation | Reoperation rate of CSDH between groups | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological disability | Assessed by the modified Rankin Scale (mRS). Numerical scale with scores between 0 and 6 (0 = no symptoms, 6= death) | 3 months and 12 months |
| Quality of Life (EQ-5D) | Assessed by the EuroQol EQ-5D scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Åke Holmberg | Contact | +46739660740 | ake.holmberg@regionstockholm.se | |
| Johan Wassélius, MD, PhD | Contact | johan.wasselius@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mattias Drake, MD | Skåne University Hospital, Lund University, Lund Sweden | Principal Investigator |
| Johan Wassélius, MD, PhD | Skåne University Hospital, Lund University, Lund Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgenska University Hospital | Not yet recruiting | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36348417 | Derived | Drake M, Ullberg T, Nittby H, Marklund N, Wasselius J. Swedish trial on embolization of middle meningeal artery versus surgical evacuation in chronic subdural hematoma (SWEMMA)-a national 12-month multi-center randomized controlled superiority trial with parallel group assignment, open treatment allocation and blinded clinical outcome assessment. Trials. 2022 Nov 8;23(1):926. doi: 10.1186/s13063-022-06842-4. |
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| OTHER |
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telephone interview at 3 and 12 months by clinical outcomes assessor blinded to treatment.
| Standard neurosurgical hematoma evacuation | Procedure | Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage. |
|
|
| 3 months and 12 months |
| Residual hematoma volume | Change in hematoma volume from pre-, post operative, and follow up head CT | 3 months |
| Technical success rate | Rate of technically successful embolizations performed | 24 hours |
| Procedure related complication rate (Safety) | Difference in number and severity of complications between endovascular and surgical participants | 3 months |
| Composite endpoint | Death or reoperation | 3 and 12 months |
| Skåne University Hospital | Recruiting | Lund | 22185 | Sweden |
|
| Karolinska Hospital | Not yet recruiting | Stockholm | 17176 | Sweden |
|
| Norrlands Universitetssjukhus | Recruiting | Umeå | 90737 | Sweden |
|
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| 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 |
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| ID | Term |
|---|---|
| D014207 | Trephining |
| ID | Term |
|---|---|
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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