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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical treatment alone | Other | Medical treatment without embolization of the MMA. |
|
| Surgical treatment alone | Other | Surgical treatment without embolization of the MMA. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical treatment | Other | Medical treatment alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of CSH recurrence defined by the composite endpoint | CSH recurrence defined by the composite endpoint:
| At 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of symptomatic CSH during the FU period | Number of symptomatic CSH during the FU period | At 6 month |
| Number of secondary surgical management during the FU period | Number of secondary surgical management during the FU period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jean-Christophe GENTRIC, PhD | Contact | 0298347520 | jean-christophe.gentric@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Terminated | Amiens | France | 80054 | France | |
| CHU Brest |
All collected data that underlie results in a publication
Data will be available beginning three years and ending fifteen years following the final study report completion.
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.
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| 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. |
|
| At 6 month |
| Number of remaining or reaccumulated hematoma on NCCT | Number of remaining or reaccumulated hematoma on NCCT | At 6 month |
| Clinical efficacy | Mortality rate | At 6 month |
| Clinical efficacy | Shift Modified Rankin Scale (mRS) (min = 0 = better outcome, max = 5 = worse outcome) | At 6 month |
| Clinical efficacy | Rapid Arterial oCclusion Exam (RACE) score evaluation (min = 0 = better outcome, max = 9 = worse outcome) | At 6 month |
| Clinical efficacy | Quality of life of patients will be evaluated by the EuroQol-5Dimensions-5L questionnaire | At 6 month |
| Clinical efficacy | Neurological exam : Barthel Scale (min = 0 = worse outcome, max = 100 = better outcome) | At 6 month |
| 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 |
| Complication rate of the embolization | Complication rate of the embolization | At 6 month |
| Volumetry of the CSH, calculated by the ABC/2 method. | Volumetry of the CSH, calculated by the ABC/2 method. | At 6 month |
| Maximum thickness of the CSH in mm. | Maximum thickness of the CSH in mm. | At 6 month |
| Comparison of the rate of AE in both groups | Comparison of the rate of AE in both groups | At 6 month |
| Comparison of the rate of SAE in both groups | Comparison of the rate of SAE in both groups | At 6 month |
| Recruiting |
| Brest |
| France |
| 29609 |
| France |
|
| CHU Caen | Terminated | Caen | France | 14000 | France |
| Hôpital Henri Mondor | Recruiting | Créteil | France | 94000 | France |
|
| CHU Nantes | Recruiting | Nantes | France | 44000 | France |
|
| CHU Nice | Recruiting | Nice | France | 06000 | France |
|
| Hôpital Pitié Salpêtrière | Recruiting | Paris | France | 75013 | France |
|
| Hôpital Fondation Rothschild | Recruiting | Paris | France | 75019 | France |
|
| CHU Tours | Terminated | Tours | France | 37000 | France |
| CHU Bordeaux | Recruiting | Bordeaux | 33076 | France |
|
| CHU Nancy | Recruiting | Nancy | 54035 | France |
|
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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