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Treatment of Chronic Subdural Hematoma by Corticosteroids (SUCRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02650609
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematomas Drug: Methylprednisolone Drug: Placebo Phase 3

Detailed Description:

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:

  • quality of life evolution,
  • morbidity and mortality,
  • radiological evolution of the lesions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Subdural Hematoma by Corticosteroids
Actual Study Start Date : June 24, 2016
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: 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.
Drug: Methylprednisolone
Placebo Comparator: 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.
Drug: Placebo



Primary Outcome Measures :
  1. Delay of occurrence of surgical treatment of the Chronic subdural hematomas [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Quality of life score [ Time Frame: 1, 3 and 6 months ]
    Short Form Health Survey 12 scale

  2. Time to surgical treatment [ Time Frame: during the first 6 months ]
  3. Rate of surgical treatment of the Chronic subdural hematomas [ Time Frame: 1, 3 and 6 months ]
  4. Functional scales : daily living [ Time Frame: 1, 3 and 6 months ]
    Instrumental Activities of Daily Living scale

  5. Functional scales : cognitive [ Time Frame: 1, 3 and 6 months ]
    Mini-Mental State Examination scale

  6. Functional scales : modified Rankin Scale [ Time Frame: 1, 3 and 6 months ]
    modified Rankin Scale

  7. Plasma sodium [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  8. Potassium [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  9. Fasting glucose [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  10. Occurrence of adverse events potentially related to methylprednisolone [ Time Frame: during the first 6 months ]
  11. Survival [ Time Frame: 6 months ]
  12. Radiological improvement [ Time Frame: 1, 3 and 6 months ]
    Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years old,
  • 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:

  • Diabetics patients,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650609


Locations
Show Show 17 study locations
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Xavier XM MORANDI, MD, PhD CHU Rennes
Principal Investigator: Pierre-Louis PH HENAUX, MD CHU Rennes
Principal Investigator: Pierre-Jean PL LE RESTE, MD CHU Rennes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02650609    
Other Study ID Numbers: 2015-000927-96
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rennes University Hospital:
chronic subdural hematomas
surgical treatment
corticosteroids
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids