Treatment of Chronic Subdural Hematoma by Corticosteroids
NCT ID: NCT02650609
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2016-06-24
2020-03-20
Brief Summary
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Detailed Description
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Secondary objectives are to assess the effect of methylprednisolone on:
* quality of life evolution,
* morbidity and mortality,
* radiological evolution of the lesions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Methylprednisolone
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):
* \<60 kg: 3 pills of 16 mg/day
* 60-80kg: 4 pills of 16 mg/day
* \>80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days.
Methylprednisolone
Placebo
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):
* \<60 kg: 3 pills of 16 mg/day
* 60-80kg: 4 pills of 16 mg/day
* \>80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days.
Placebo
Interventions
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Methylprednisolone
Placebo
Eligibility Criteria
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Inclusion Criteria
* With chronic or subacute, uni or bilateral subdural hematoma,
* Confirmed by cerebral scan without contrast enhancement,
* Without clinical and radiological signs of severity,
* Written informed consent from patients or their next of kin according to the patients cognitive status.
Exclusion Criteria
* Contraindication for methylprednisolone,
* Previous surgery for chronic subdural hematoma during the past 6 months,
* Pre-existing severe dementia related to other etiology than the Chronic subdural hematomas,
* Existing neurological pathology that can be associated with dementia,
* Patients treated with corticosteroids,
* Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor),
* Participating in other concomitant research.
18 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Xavier XM MORANDI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Pierre-Louis PH HENAUX, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Pierre-Jean PL LE RESTE, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Locations
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CHU Amiens
Amiens, , France
CHU Angers
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
Countries
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References
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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.
Other Identifiers
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2015-000927-96
Identifier Type: -
Identifier Source: org_study_id
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