Medical treatment
OtherMedical treatment alone
NCT Number: NCT05374681
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
CHU Amiens-Picardie, Amiens, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medical treatment alone
Surgical treatment alone
The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Time frame: At 6 month
CSH recurrence defined by the composite endpoint:
Time frame: At 6 month
Number of symptomatic CSH during the FU period
Time frame: At 6 month
Number of secondary surgical management during the FU period
Time frame: At 6 month
Number of remaining or reaccumulated hematoma on NCCT
Time frame: At 6 month
Mortality rate
Time frame: At 6 month
Shift Modified Rankin Scale (mRS) (min = 0 = better outcome, max = 5 = worse outcome)
Time frame: At 6 month
Rapid Arterial oCclusion Exam (RACE) score evaluation (min = 0 = better outcome, max = 9 = worse outcome)
Time frame: At 6 month
Quality of life of patients will be evaluated by the EuroQol-5Dimensions-5L questionnaire
Time frame: At 6 month
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)).
Time frame: At 6 month
Complication rate of the embolization
Time frame: At 6 month
Volumetry of the CSH, calculated by the ABC/2 method.
Time frame: At 6 month
Maximum thickness of the CSH in mm.
Time frame: At 6 month
Comparison of the rate of AE in both groups
Time frame: At 6 month
Comparison of the rate of SAE in both groups
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
LEADH: Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization : Liquid Embolic Agent for the Treatment of Chronic subDural Hematoma a Randomized Control Study
Acronym: LEADH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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