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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

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 8, 2016
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE June 24, 2016
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
Delay of occurrence of surgical treatment of the Chronic subdural hematomas [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • Quality of life score [ Time Frame: 1, 3 and 6 months ]
    Short Form Health Survey 12 scale
  • Time to surgical treatment [ Time Frame: during the first 6 months ]
  • Rate of surgical treatment of the Chronic subdural hematomas [ Time Frame: 1, 3 and 6 months ]
  • Functional scales : daily living [ Time Frame: 1, 3 and 6 months ]
    Instrumental Activities of Daily Living scale
  • Functional scales : cognitive [ Time Frame: 1, 3 and 6 months ]
    Mini-Mental State Examination scale
  • Functional scales : modified Rankin Scale [ Time Frame: 1, 3 and 6 months ]
    modified Rankin Scale
  • Plasma sodium [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  • Potassium [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  • Fasting glucose [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  • Occurrence of adverse events potentially related to methylprednisolone [ Time Frame: during the first 6 months ]
  • Survival [ Time Frame: 6 months ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Quality of life [ Time Frame: 1, 3 and 6 months ]
    Short Form Health Survey 12 scale
  • Time to surgical treatment [ Time Frame: during the first 6 months ]
  • Rate of surgical treatment of the Chronic subdural hematomas [ Time Frame: 1, 3 and 6 months ]
  • Functional scales : daily living [ Time Frame: 1, 3 and 6 months ]
    Instrumental Activities of Daily Living scale
  • Functional scales : cognitive [ Time Frame: 1, 3 and 6 months ]
    Mini-Mental State Examination scale
  • Functional scales : modified Rankin Scale [ Time Frame: 1, 3 and 6 months ]
    modified Rankin Scale
  • Plasma sodium [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  • Potassium [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  • Fasting glucose [ Time Frame: day 0, 7, 14, and 21 and 1 month ]
  • Occurrence of adverse events potentially related to methylprednisolone [ Time Frame: during the first 6 months ]
  • Survival [ Time Frame: 6 months ]
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Chronic Subdural Hematoma by Corticosteroids
Official Title  ICMJE Treatment of Chronic Subdural Hematoma by Corticosteroids
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematomas
Intervention  ICMJE
  • Drug: Methylprednisolone
  • Drug: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2016)
202
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 20, 2020
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02650609
Other Study ID Numbers  ICMJE 2015-000927-96
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Rennes University Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP