Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05267184
Study type Interventional
Source Region Skane
Contact Åke Holmberg
Phone +46739660740
Email ake.holmberg@regionstockholm.se
Status Recruiting
Phase N/A
Start date March 28, 2022
Completion date March 2027

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06347796 - Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study N/A
Recruiting NCT04065113 - Middle Meningeal Artery Embolization for Chronic Subdural Hematoma N/A
Recruiting NCT02938468 - Mgt of Chronic Subdural Hematoma Using Dexamethasone Phase 2/Phase 3
Completed NCT03307395 - Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma N/A
Terminated NCT04502745 - A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation N/A
Terminated NCT03353259 - Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery Phase 2/Phase 3
Recruiting NCT02568124 - Tranexamic Acid in Chronic Subdural Hematomas Phase 2/Phase 3
Completed NCT02282228 - Detecting Chronic Subdural Hematoma With Microwave Technology N/A
Recruiting NCT05143216 - High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study
Active, not recruiting NCT04816591 - Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA N/A
Recruiting NCT06401772 - The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma N/A
Completed NCT06134206 - Burr Hole Ultrasound Study N/A
Recruiting NCT03666949 - General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma N/A
Recruiting NCT03280212 - Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma Phase 3
Completed NCT03447327 - Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma N/A
Recruiting NCT05374681 - Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization N/A
Not yet recruiting NCT05900557 - Neurologic Deficits and Recovery in Chronic Subdural Hematoma N/A
Completed NCT02757235 - The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma N/A
Terminated NCT02111785 - Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma Phase 2/Phase 3
Recruiting NCT05599217 - Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)