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

Chronic Subdural Hematoma Clinical Trial

— LEADH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374681
• Other study ID #: 29BRC22.0028
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: September 28, 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Brest
• Contact: jean-Christophe GENTRIC, PhD
• Phone: 0298347520
• Email: jean-christophe.gentric[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• Indication of surgical or conservative management will be decided by the neurosurgeon.

• Experimental arm:

CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.

Medical management will be adopted according to neurosurgeons habits. MMA embolization (on the CSH side or bilaterally if necessary) in the Experimental Arms will be performed with Cyanoacrylates and preferentially using conscious sedation or local anesthesia.

• Control arm: CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.

Medical management will be adopted according to neurosurgeons habits

• Primary and secondary end points will be assessed at 2 months+/- 1 month and assessed at 6 +/- 2 months. The blind items will be the mRS and the RACE score. The volume of the CSH will be semi-automatically assessed using the ABC/2 method and the estimated maximal thickness of the CSH on axial images.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: September 28, 2026
• Est. primary completion date: September 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, 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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Other:
• Medical treatment
Medical treatment alone
• Surgical treatment
Surgical treatment alone
• embolization of the MMA
The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	CHU Bordeaux	Bordeaux
France	CHU Brest	Brest
France	CHU Caen	Caen
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	Hôpital Pitié Salpêtrière	Paris
France	CHU Tours	Tours
Martinique	CHU Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CSH recurrence defined by the composite endpoint	CSH recurrence defined by the composite endpoint: A symptomatic CSH during the 6 month FU period; A secondary surgical management during the 6 months FU period; A remaining or reaccumulated hematoma on NCCT at 6 months	At 6 month
Secondary	Number of symptomatic CSH during the FU period	Number of symptomatic CSH during the FU period	At 6 month
Secondary	Number of secondary surgical management during the FU period	Number of secondary surgical management during the FU period	At 6 month
Secondary	Number of remaining or reaccumulated hematoma on NCCT	Number of remaining or reaccumulated hematoma on NCCT	At 6 month
Secondary	Clinical efficacy	Mortality rate	At 6 month
Secondary	Clinical efficacy	Shift Modified Rankin Scale (mRS) (min = 0 = better outcome, max = 5 = worse outcome)	At 6 month
Secondary	Clinical efficacy	Rapid Arterial oCclusion Exam (RACE) score evaluation (min = 0 = better outcome, max = 9 = worse outcome)	At 6 month
Secondary	Clinical efficacy	Quality of life of patients will be evaluated by the EuroQol-5Dimensions-5L questionnaire	At 6 month
Secondary	Clinical efficacy	Neurological exam : Barthel Scale (min = 0 = worse outcome, max = 100 = better outcome)	At 6 month
Secondary	Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).	Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).	At 6 month
Secondary	Complication rate of the embolization	Complication rate of the embolization	At 6 month
Secondary	Volumetry of the CSH, calculated by the ABC/2 method.	Volumetry of the CSH, calculated by the ABC/2 method.	At 6 month
Secondary	Maximum thickness of the CSH in mm.	Maximum thickness of the CSH in mm.	At 6 month
Secondary	Comparison of the rate of AE in both groups	Comparison of the rate of AE in both groups	At 6 month
Secondary	Comparison of the rate of SAE in both groups	Comparison of the rate of SAE in both groups	At 6 month