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

NCT05374681 | Recruiting

• 1 other identifier: 29BRC22.0028
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic Subdural Hematoma

Keywords

Cyanoacrylate; Embolization; Middle meningeal artery; Recurrence of chronic subdural hematoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Number of symptomatic CSH during the FU period

  At 6 month

• Number of secondary surgical management during the FU period

  At 6 month

• Number of remaining or reaccumulated hematoma on NCCT

  At 6 month

• Clinical efficacy

  At 6 month

• Clinical efficacy

  At 6 month

Study Arms (4)

Medical treatment alone

OTHER

Medical treatment without embolization of the MMA.

Other: Medical treatment

Surgical treatment alone

OTHER

Surgical treatment without embolization of the MMA.

Other: Surgical treatment

Medical treatment associated with an embolization of the MMA

EXPERIMENTAL

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.

Other: Medical treatment; Other: embolization of the MMA

Surgical treatment associated with an embolization of the MMA

EXPERIMENTAL

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.

Other: Surgical treatment; Other: embolization of the MMA

Interventions

Medical treatment OTHER

Medical treatment alone

Medical treatment alone; Medical treatment associated with an embolization of the MMA

Surgical treatment OTHER

Surgical treatment alone

Surgical treatment alone; Surgical treatment associated with an embolization of the MMA

embolization of the MMA OTHER

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

Medical treatment associated with an embolization of the MMA; Surgical treatment associated with an embolization of the MMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (11)

CHU Amiens-Picardie

Amiens, France, 80054, France

TERMINATED

CHU Brest

Brest, France, 29609, France

RECRUITING

CHU Caen

Caen, France, 14000, France

TERMINATED

Hôpital Henri Mondor

Créteil, France, 94000, France

RECRUITING

CHU Nantes

Nantes, France, 44000, France

RECRUITING

CHU Nice

Nice, France, 06000, France

RECRUITING

Hôpital Pitié Salpêtrière

Paris, France, 75013, France

RECRUITING

Hôpital Fondation Rothschild

Paris, France, 75019, France

RECRUITING

CHU Tours

Tours, France, 37000, France

TERMINATED

CHU Bordeaux

Bordeaux, 33076, France

RECRUITING

CHU Nancy

Nancy, 54035, France

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Central Study Contacts

jean-Christophe GENTRIC, PhD

CONTACT

0298347520; jean-christophe.gentric@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 16, 2022
• Study Start: March 28, 2023
• Primary Completion (Estimated): September 28, 2028
• Study Completion (Estimated): September 28, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion.
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (11)