Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization

Recruiting now · Not applicable

Conditions studied: Chronic Subdural Hematoma

In brief

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.

Key facts

Study ID

NCT05374681

Run by

University Hospital, Brest

People needed

550

Starts

2023-03-28

Expected to finish

2028-09-28

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with a more than 10 mm CSH confirmed by NCCT
• CSH localized to convexity
• Patient aged 18 years or more at the time of the enrollment
• Patient beneficiary from health insurance

You may not qualify if…

• Any contraindication as required per angiogram procedure (severe renal failure ≥ 4, allergy…)
• Pre-existing severe disability resulting in baseline mRS score > 3
• Life expectancy of less than 6 months due to another cause than CSH
• Patient under legal protection or deprived of liberty by a judicial or administrative decision
• Pregnant or breastfeeding women
• Vulnerable persons unable to give consent

Where it is running

• CHU Nancy — Nancy, France (enrolling)
• CHU Brest — Brest, France, France (enrolling)
• Hôpital Pitié Salpêtrière — Paris, France, France (enrolling)
• Hôpital Fondation Rothschild — Paris, France, France (enrolling)
• CHU Bordeaux — Bordeaux, France (enrolling)
• Hôpital Henri Mondor — Créteil, France, France (enrolling)
• CHU Nantes — Nantes, France, France (enrolling)
• CHU Nice — Nice, France, France (enrolling)
• CHU Caen — Caen, France, France
• CHU Amiens-Picardie — Amiens, France, France
• CHU Tours — Tours, France, France

Full record on ClinicalTrials.gov

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