Condition: Chronic Subdural Hematoma · Sponsor: University Hospital, Brest
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…
This description comes directly from the study's public registry record.
jean-Christophe GENTRIC, PhD · 0298347520 · jean-christophe.gentric@chu-brest.fr
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| CHU Amiens-Picardie | Amiens, France, France | Terminated |
| CHU Brest | Brest, France, France | Recruiting |
| CHU Caen | Caen, France, France | Terminated |
| Hôpital Henri Mondor | Créteil, France, France | Recruiting |
| CHU Nantes | Nantes, France, France | Recruiting |
| CHU Nice | Nice, France, France | Recruiting |
| Hôpital Pitié Salpêtrière | Paris, France, France | Recruiting |
| Hôpital Fondation Rothschild | Paris, France, France | Recruiting |
| CHU Tours | Tours, France, France | Terminated |
| CHU Bordeaux | Bordeaux, France | Recruiting |
| CHU Nancy | Nancy, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05374681