RecruitingNot ApplicableNCT05374681

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

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


Sponsor

University Hospital, Brest

Enrollment

550 participants

Start Date

Mar 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a minimally invasive procedure called cyanoacrylate embolization (sealing a blood vessel with medical glue) can help treat chronic subdural hematoma (CSH) — a collection of blood on the surface of the brain that causes headaches, confusion, or weakness. This procedure may be used alongside or instead of the usual surgical drainage. You may be eligible if... - You are 18 years or older - A CT scan has confirmed a chronic subdural hematoma larger than 10 mm on the outer surface (convexity) of the brain - You have health insurance coverage You may NOT be eligible if... - You have severe kidney failure or allergy that prevents an angiogram procedure - You have a pre-existing severe disability (mRS score above 3) - Your life expectancy is less than 6 months due to another illness - You are pregnant or breastfeeding - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMedical treatment

Medical treatment alone

OTHERSurgical treatment

Surgical treatment alone

OTHERembolization of the MMA

The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.


Locations(11)

CHU Amiens-Picardie

Amiens, France, France

CHU Brest

Brest, France, France

CHU Caen

Caen, France, France

Hôpital Henri Mondor

Créteil, France, France

CHU Nantes

Nantes, France, France

CHU Nice

Nice, France, France

Hôpital Pitié Salpêtrière

Paris, France, France

Hôpital Fondation Rothschild

Paris, France, France

CHU Tours

Tours, France, France

CHU Bordeaux

Bordeaux, France

CHU Nancy

Nancy, France

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NCT05374681


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