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Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.
The primary objective is to evaluate the efficacy of corticosteroids treatment in patients with Chronic subdural hematomas without clinical or radiological signs of severity.
Secondary objectives are to assess the effect of methylprednisolone on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Experimental | Methylprednisolone will be supplied as powder and stored in capsules containing 16 mg with lactose as excipient. Capsules will be administered orally in the morning, during breakfast with a glass of water. Dose is adapted according to the weight of the patient (1mg/kg):
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| Placebo | Placebo Comparator | Placebo capsules will only contain lactose. Capsules will be administered orally in the morning, during breakfast with a glass of water. Dose is adapted according to the weight of the patient (1mg/kg):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Delay of occurrence of surgical treatment of the Chronic subdural hematomas | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life score | Short Form Health Survey 12 scale | 1, 3 and 6 months |
| Time to surgical treatment | during the first 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier XM MORANDI, MD, PhD | Rennes University Hospital | Principal Investigator |
| Pierre-Louis PH HENAUX, MD | Rennes University Hospital | Principal Investigator |
| Pierre-Jean PL LE RESTE, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | France | ||||
| CHU Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41999149 | Derived | Fougerou-Leurent C, Forteau L, Perrot-Loyer M, Renault A, Brion M, Mouchel C, Rousseau C, Marion E, Cochennec S, Ganivet A, Gervais ML, Fin L, Laviolle B. Evaluating the Environmental Impact of Clinical Research: A Full Life Cycle Analysis of a French Academic Randomised Clinical Trial. Fundam Clin Pharmacol. 2026 May;40(3):e70086. doi: 10.1111/fcp.70086. | |
| 28583162 |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
| Rate of surgical treatment of the Chronic subdural hematomas |
| 1, 3 and 6 months |
| Functional scales : daily living | Instrumental Activities of Daily Living scale | 1, 3 and 6 months |
| Functional scales : cognitive | Mini-Mental State Examination scale | 1, 3 and 6 months |
| Functional scales : modified Rankin Scale | modified Rankin Scale | 1, 3 and 6 months |
| Plasma sodium | day 0, 7, 14, and 21 and 1 month |
| Potassium | day 0, 7, 14, and 21 and 1 month |
| Fasting glucose | day 0, 7, 14, and 21 and 1 month |
| Occurrence of adverse events potentially related to methylprednisolone | during the first 6 months |
| Survival | 6 months |
| Radiological improvement | Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated | 1, 3 and 6 months |
| Angers |
| France |
| CHU Besançon | Besançon | France |
| CHU Bordeaux Neurochirurgie A | Bordeaux | France |
| CHU Bordeaux Neurochirurgie B | Bordeaux | France |
| CHU Brest | Brest | France |
| CHU Caen | Caen | France |
| CHU Lille | Lille | France |
| HC Lyon | Lyon | France |
| AP-HM - Hôpital La Timone | Marseille | France |
| CHU Nancy | Nancy | France |
| CHU Nantes | Nantes | France |
| CHU Poitiers | Poitiers | France |
| CHU Rouen | Rouen | France |
| CHU Saint Etienne | Saint-Etienne | France |
| CHU Strasbourg | Strasbourg | France |
| CHU Tours | Tours | France |
| Henaux PL, Le Reste PJ, Laviolle B, Morandi X. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):252. doi: 10.1186/s13063-017-1990-8. |
| 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 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |