Treatment of Chronic Subdural Hematoma by Corticosteroids
SUCRE
1 other identifier
interventional
202
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2016
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 8, 2016
CompletedStudy Start
First participant enrolled
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2020
CompletedJune 9, 2020
June 1, 2020
2.7 years
January 4, 2016
June 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
1 month
Secondary Outcomes (12)
Quality of life score
1, 3 and 6 months
Time to surgical treatment
during the first 6 months
Rate of surgical treatment of the Chronic subdural hematomas
1, 3 and 6 months
Functional scales : daily living
1, 3 and 6 months
Functional scales : cognitive
1, 3 and 6 months
- +7 more secondary outcomes
Study Arms (2)
Methylprednisolone
EXPERIMENTALMethylprednisolone 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.
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
Related Publications (1)
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.
PMID: 28583162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 8, 2016
Study Start
June 24, 2016
Primary Completion
March 20, 2019
Study Completion
March 20, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share