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

NCT05267184 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2024-04-09

No results posted yet for this study

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

Interventions

PROCEDURE

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.

PROCEDURE

Standard neurosurgical hematoma evacuation

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

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Norrlands University Hospital

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Mattias Drake, MD · Skåne University Hospital, Lund University, Lund Sweden

  • Johan Wassélius, MD, PhD · Skåne University Hospital, Lund University, Lund Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267184 on ClinicalTrials.gov