Treatment of Chronic Subdural Hematoma by Corticosteroids (SUCRE)
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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 |
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Recruitment Status :
Completed
First Posted : January 8, 2016
Last Update Posted : June 9, 2020
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Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
| Tracking Information | ||||||||||
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| 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 |
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 |
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| Original Secondary Outcome Measures ICMJE |
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| 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:
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| 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 |
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| Condition ICMJE | Chronic Subdural Hematomas | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| Responsible Party | Rennes University Hospital | |||||||||
| Study Sponsor ICMJE | Rennes University Hospital | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Rennes University Hospital | |||||||||
| Verification Date | June 2020 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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