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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Brest
NCT05374681 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Medical treatment
  • Surgical treatment
  • embolization of the MMA
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Where

11 sites
CHU Amiens-Picardie
Amiens, France
CHU Brest
Brest, France
CHU Caen
Caen, France
Hôpital Henri Mondor
Créteil, France
CHU Nantes
Nantes, France
CHU Nice
Nice, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Fondation Rothschild
Paris, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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