Endovascular Embolization of Chronic Subdural Hematomas After Surgery (ENCLOSURE)
Chronic Subdural Hematoma
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Middle meningeal artery embolization
Eligibility Criteria
Inclusion Criteria:
- Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect.
- Recent diagnosis or recurrence
- Surgical treatment performed < 72 hours
- Informed consent signed by the patient or they responsible family member
Exclusion Criteria:
- Advanced disease with life expectancy < 6 months
- Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence < 30 ml/min, allergy to iodinated contrast.
- Unavailability for follow up st 6 months
- Patient expressly refuses treatment
Sites / Locations
- Hospital Universitari Vall d'HebronRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Surgical drainaje (the standar of care)
Surgical drainaje plus early embolization of middle meningeal artery
Surgery will consist of performing a craniotomy (burr hole or drill) and evacuation of the hematoma. Depending on the operator, the surgical procedure may incorporate the use of subdural space drainage devices (e.g. Jackson Pratt drainage) connected to a soft suction reservoir. If used, these devices should be removed within 48 hours of installation.
The endovascular procedure will be performed until 72 hours after surgical evacuation of chronic subdural hematoma. Embolization will be performed with non-adhesive embolizing fluids such as Onix®, Phil®, Squid® or Libro®.