NCT05374681 Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization
| NCT ID | NCT05374681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2023-03-28 |
| Primary Completion | 2028-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 550 participants in total. It began in 2023-03-28 with a primary completion date of 2028-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05374681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05374681 currently recruiting?
Yes, NCT05374681 is actively recruiting participants. Contact the research team at jean-christophe.gentric@chu-brest.fr for enrollment information.
Where is the NCT05374681 trial being conducted?
This trial is being conducted at Amiens, France, Brest, France, Caen, France, Créteil, France and 7 additional locations.
Who is sponsoring the NCT05374681 clinical trial?
NCT05374681 is sponsored by University Hospital, Brest. The trial plans to enroll 550 participants.