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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Amiens-Picardie
RECRUITING
Amiens
CHU Bordeaux
RECRUITING
Bordeaux
CHU Brest
RECRUITING
Brest
CHU Caen
RECRUITING
Caen
CHU Nancy
RECRUITING
Nancy
CHU Nantes
RECRUITING
Nantes
Hôpital Pitié Salpêtrière
RECRUITING
Paris
CHU Tours
RECRUITING
Tours
Martinique
CHU Martinique
NOT_YET_RECRUITING
Fort-de-france
Contact Information
Primary
jean-Christophe GENTRIC, PhD
jean-christophe.gentric@chu-brest.fr
0298347520
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2026-09-28
Participants
Target number of participants: 550
Treatments
Other: Medical treatment alone
Medical treatment without embolization of the MMA.
Other: Surgical treatment alone
Surgical treatment without embolization of the MMA.
Experimental: Medical treatment associated with an embolization of the MMA
Medical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Experimental: Surgical treatment associated with an embolization of the MMA
Surgical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov