Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05374681

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

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical treatment

Other

Medical treatment alone

Surgical treatment

Other

Surgical treatment alone

embolization of the MMA

Other

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

Primary outcomes

  1. Number of CSH recurrence defined by the composite endpoint

    Time frame: At 6 month

    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

Secondary outcomes

  1. Number of symptomatic CSH during the FU period

    Time frame: At 6 month

    Number of symptomatic CSH during the FU period

  2. Number of secondary surgical management during the FU period

    Time frame: At 6 month

    Number of secondary surgical management during the FU period

  3. Number of remaining or reaccumulated hematoma on NCCT

    Time frame: At 6 month

    Number of remaining or reaccumulated hematoma on NCCT

  4. Clinical efficacy

    Time frame: At 6 month

    Mortality rate

  5. Clinical efficacy

    Time frame: At 6 month

    Shift Modified Rankin Scale (mRS) (min = 0 = better outcome, max = 5 = worse outcome)

  6. Clinical efficacy

    Time frame: At 6 month

    Rapid Arterial oCclusion Exam (RACE) score evaluation (min = 0 = better outcome, max = 9 = worse outcome)

  7. Clinical efficacy

    Time frame: At 6 month

    Quality of life of patients will be evaluated by the EuroQol-5Dimensions-5L questionnaire

  8. Clinical efficacy

    Time frame: At 6 month

    Neurological exam : Barthel Scale (min = 0 = worse outcome, max = 100 = better outcome)

  9. Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).

    Time frame: At 6 month

    Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).

  10. Complication rate of the embolization

    Time frame: At 6 month

    Complication rate of the embolization

  11. Volumetry of the CSH, calculated by the ABC/2 method.

    Time frame: At 6 month

    Volumetry of the CSH, calculated by the ABC/2 method.

  12. Maximum thickness of the CSH in mm.

    Time frame: At 6 month

    Maximum thickness of the CSH in mm.

  13. Comparison of the rate of AE in both groups

    Time frame: At 6 month

    Comparison of the rate of AE in both groups

  14. Comparison of the rate of SAE in both groups

    Time frame: At 6 month

    Comparison of the rate of SAE in both groups

Study contacts

Contact information is provided by the study sponsor or research team.

jean-Christophe GENTRIC, PhD

CONTACT

[email protected]

0298347520

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Acronym: LEADH

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 16, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.