Informations générales (source: ClinicalTrials.gov)
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 (LEADH)
Interventional
N/A
University Hospital, Brest (Voir sur ClinicalTrials)
mars 2023
septembre 2026
05 avril 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Amiens-Picardie - 80054 - Amiens - France | Cyril CHIVOT, Dr | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - 33076 - Bordeaux - France | Gaultier MARNAT, Dr | Contact (sur clinicalTrials) | |||
| CHU Brest - 29609 - Brest - France | Jean-Christophe GENTRIC, PhD | Contact (sur clinicalTrials) | |||
| CHU Caen - 14000 - Caen - France | Charlotte BARBIER, Dr | Contact (sur clinicalTrials) | |||
| CHU Nancy - 54035 - Nancy - France | Benjamin GORY, Pr | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44000 - Nantes - France | Romain BOURCIER, Dr | Contact (sur clinicalTrials) | |||
| CHU Tours - 37000 - Tours - France | Grégoire BOULOUIS, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Pitié Salpêtrière - 75013 - Paris - France | Frédéric CLARENCON, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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