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

Study acronym: LEADH
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Primary and study completion dates: Sep 28, 2026 to Sep 28, 2028
    • Study sites: 9 to 11
    • Eligibility criteria expanded, about 8 words
    v6
  3. Site details revised at 6 of 9 sitesv5
  4. Site details revised at 4 of 9 sitesv4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary and study completion dates: Apr 1, 2026 to Sep 28, 2026
    • Start date changed from estimate of Oct 1, 2022 to Mar 28, 2023
    • Eligibility criteria revised
    • Site details revised at 9 of 9 sites
  6. Start date: Jul 1, 2022 to Oct 1, 2022
    • Primary and study completion dates: Jan 1, 2026 to Apr 1, 2026
    • Eligibility criteria shortened, about 28 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05374681
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)		 Chronic Subdural Hematoma
Related terms Hematoma, Subdural, Chronic
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov