Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma

NCT ID: NCT05267184

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2027-03-31

Brief Summary

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).

Detailed Description

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.

Conditions

Chronic Subdural Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Embolization of middle meningeal artery

Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s).

Group Type: EXPERIMENTAL

Endovascular treatment of the middle meningeal artery

Intervention Type: PROCEDURE

The middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents.

Standard neurosurgical hematoma evacuation and drainage

Participants receive standard neurosurgical hematoma evacuation via burr hole or mini craniotomy and post-operative subdural or subgaleal drainage.

Group Type: ACTIVE_COMPARATOR

Standard neurosurgical hematoma evacuation

Intervention Type: PROCEDURE

Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.

Interventions

Endovascular treatment of the middle meningeal artery

The middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents.

Intervention Type: PROCEDURE

Standard neurosurgical hematoma evacuation

Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.

Intervention Type: PROCEDURE

Other Intervention Names

burr-hole, mini craniotomy

Eligibility Criteria

Inclusion Criteria

1. Men and women 18-89 y/o

2. Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH

3. Clinical and/or radiological status indicating neurosurgical treatment

4. Markwalder Scale score <2

5. Glasgow coma Scale score >13

6. Able to provide signed informed consent

Exclusion Criteria

1. Acute subdural hematoma

2. Focal, non-hemispheric cSDH

3. Midline shift >10 mm and/or effaced basal cisterns and/or significant dilatation of one or both lateral ventricle temporal horns and/or incipient uncal herniation

4. Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)

5. Contraindications to angiography

6. Dependency defined as mRS >3

7. Life expectancy <6 months

8. Comorbidity deemed making follow up impossible

9. Participation in other interventional clinical study

10. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Norrlands University Hospital

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mattias Drake, MD

Role: PRINCIPAL_INVESTIGATOR

Skåne University Hospital, Lund University, Lund Sweden

Johan Wassélius, MD, PhD

Role: STUDY_DIRECTOR

Skåne University Hospital, Lund University, Lund Sweden

Locations

Sahlgenska University Hospital

Gothenburg, , Sweden

Site Status: NOT_YET_RECRUITING

Skåne University Hospital

Lund, , Sweden

Site Status: RECRUITING

Karolinska Hospital

Stockholm, , Sweden

Site Status: NOT_YET_RECRUITING

Norrlands Universitetssjukhus

Umeå, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Åke Holmberg

Role: CONTACT

ake.holmberg@regionstockholm.se

+46739660740

Johan Wassélius, MD, PhD

Role: CONTACT

johan.wasselius@gmail.com

Facility Contacts

Erik Ceder, MD, PhD

Role: primary

erik.ceder@vgregion.se

Magnus Tisell, MD, PhD

Role: backup

magnus.tisell@gu.se

Åke Holmberg

Role: primary

ake.holmberg@regionstockholm.se

+46739660740

Fabian Arnberg, MD, PhD

Role: primary

fabian.arnberg@regionstockholm.se

Jiri Bartek, MD, PhD

Role: backup

jiri.bartek@ki.se

Peter Lindvall, MD, PhD

Role: primary

Peter.Lindvall@regionvasterbotten.se

Alexander Henze, MD

Role: backup

Alexander.Henze@regionvasterbotten.se

References

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.

Reference Type: DERIVED

PMID: 36348417 (View on PubMed)

Other Identifiers

2021/02670

Identifier Type: -

Identifier Source: org_study_id