An interventional study of Medical treatment and Surgical treatment in Chronic Subdural Hematoma, sponsored by University Hospital, Brest. Recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Other
Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose.
Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences.
The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.
CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.
Medical management will be adopted according to neurosurgeons habits. MMA embolization (on the CSH side or bilaterally if necessary) in the Experimental Arms will be performed with Cyanoacrylates and preferentially using conscious sedation or local anesthesia.
Medical management will be adopted according to neurosurgeons habits
114 studies on the registry are indexed under Hematoma, Subdural, Chronic; 48 are open to participants now.
This study's planned enrollment of 550 is above the median of 164 across 87 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medical treatment without embolization of the MMA.
Other: Medical treatment
Surgical treatment without embolization of the MMA.
Other: Surgical treatment
Medical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Other: Medical treatment · Other: embolization of the MMA
Surgical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Other: Surgical treatment · Other: embolization of the MMA
Medical treatment alone
Surgical treatment alone
The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Number of CSH recurrence defined by the composite endpoint
CSH recurrence defined by the composite endpoint: * A symptomatic CSH during the 6 month FU period * A secondary surgical management during the 6 months FU period * A remaining or reaccumulated hematoma on NCCT at 6 months
Time frame: At 6 month
Number of symptomatic CSH during the FU period
Number of symptomatic CSH during the FU period
Time frame: At 6 month
Number of secondary surgical management during the FU period
Number of secondary surgical management during the FU period
Time frame: At 6 month
Number of remaining or reaccumulated hematoma on NCCT
Number of remaining or reaccumulated hematoma on NCCT
Time frame: At 6 month
Clinical efficacy
Mortality rate
Time frame: At 6 month
Clinical efficacy
Shift Modified Rankin Scale (mRS) (min = 0 = better outcome, max = 5 = worse outcome)
Time frame: At 6 month
Clinical efficacy
Rapid Arterial oCclusion Exam (RACE) score evaluation (min = 0 = better outcome, max = 9 = worse outcome)
Time frame: At 6 month
Clinical efficacy
Quality of life of patients will be evaluated by the EuroQol-5Dimensions-5L questionnaire
Time frame: At 6 month
Clinical efficacy
Neurological exam : Barthel Scale (min = 0 = worse outcome, max = 100 = better outcome)
Time frame: At 6 month
Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).
Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).
Time frame: At 6 month
Complication rate of the embolization
Complication rate of the embolization
Time frame: At 6 month
Volumetry of the CSH, calculated by the ABC/2 method.
Volumetry of the CSH, calculated by the ABC/2 method.
Time frame: At 6 month
Maximum thickness of the CSH in mm.
Maximum thickness of the CSH in mm.
Time frame: At 6 month
Comparison of the rate of AE in both groups
Comparison of the rate of AE in both groups
Time frame: At 6 month
Comparison of the rate of SAE in both groups
Comparison of the rate of SAE in both groups
Time frame: At 6 month
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
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University Hospital, Brest