NCT Number: NCT02650609
Treatment of Chronic Subdural Hematoma by Corticosteroids
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
CHU Amiens, Amiens, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
Time frame: 1 month
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Rennes University Hospital
Other
Registry information
Acronym: SUCRE
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Jan 8, 2016
- Registry last updated
- Jun 9, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Prospective MMA Embolization Registry
NCT07626671
Brain Diseases, Cardiovascular Diseases
View Trial DetailsPHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
NCT07576998
Brain Diseases, Cardiovascular Diseases
View Trial DetailsProspective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
NCT07556991
Brain Diseases, Cardiovascular Diseases
Rostock, Germany
View Trial DetailsMiddle Meningeal Artery Coagulation During Burr-Hole Drainage for Chronic Subdural Haematoma (BURR-MMA)
NCT07549893
Brain Diseases, Cardiovascular Diseases
View Trial Details