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

NCT05267184 | Recruiting DMC

• 1 other identifier: 2021/02670
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 4

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).

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• Reoperation

  Reoperation rate of CSDH between groups

  3 months

Secondary Outcomes (6)

• Neurological disability

  3 months and 12 months

• Quality of Life (EQ-5D)

  3 months and 12 months

• Residual hematoma volume

  3 months

• Technical success rate

  24 hours

• Procedure related complication rate (Safety)

  3 months

Study Arms (2)

Embolization of middle meningeal artery

EXPERIMENTAL

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

Procedure: Endovascular treatment of the middle meningeal artery

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.

Procedure: Standard neurosurgical hematoma evacuation

Interventions

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.

Embolization of middle meningeal artery

Standard neurosurgical hematoma evacuation PROCEDURE

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

Also known as: burr-hole, mini craniotomy

Standard neurosurgical hematoma evacuation and drainage

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-89 y/o
• Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH
• Clinical and/or radiological status indicating neurosurgical treatment
• Markwalder Scale score \<2
• Glasgow coma Scale score \>13
• Able to provide signed informed consent

You may not qualify if:

• Acute subdural hematoma
• Focal, non-hemispheric cSDH
• 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
• Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
• Contraindications to angiography
• Dependency defined as mRS \>3
• Life expectancy \<6 months
• Comorbidity deemed making follow up impossible
• Participation in other interventional clinical study
• Pregnancy

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Sahlgrenska University Hospital: collaborator
• Karolinska University Hospital: collaborator
• Norrlands University Hospital: collaborator

Study Sites (4)

Sahlgenska University Hospital

Gothenburg, 41345, Sweden

NOT YET RECRUITING

Skåne University Hospital

Lund, 22185, Sweden

RECRUITING

Karolinska Hospital

Stockholm, 17176, Sweden

NOT YET RECRUITING

Norrlands Universitetssjukhus

Umeå, 90737, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 36348417 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Trephining

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Craniotomy; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• 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

Central Study Contacts

Åke Holmberg

CONTACT

+46739660740; ake.holmberg@regionstockholm.se

Johan Wassélius, MD, PhD

CONTACT

johan.wasselius@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: telephone interview at 3 and 12 months by clinical outcomes assessor blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 4, 2022
• Study Start: March 28, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)