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Treatment of Chronic Subdural Hematoma by Corticosteroids (SUCRE)

Primary Purpose

Chronic Subdural Hematomas

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematomas focused on measuring chronic subdural hematomas, surgical treatment, corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Amiens
  • CHU Angers
  • CHU Besançon
  • CHU Bordeaux Neurochirurgie A
  • CHU Bordeaux Neurochirurgie B
  • CHU Brest
  • CHU Caen
  • CHU Lille
  • HC Lyon
  • AP-HM - Hôpital La Timone
  • CHU Nancy
  • CHU Nantes
  • CHU Poitiers
  • CHU Rouen
  • CHU Saint Etienne
  • CHU Strasbourg
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylprednisolone

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Delay of occurrence of surgical treatment of the Chronic subdural hematomas

Secondary Outcome Measures

Quality of life score
Short Form Health Survey 12 scale
Time to surgical treatment
Rate of surgical treatment of the Chronic subdural hematomas
Functional scales : daily living
Instrumental Activities of Daily Living scale
Functional scales : cognitive
Mini-Mental State Examination scale
Functional scales : modified Rankin Scale
modified Rankin Scale
Plasma sodium
Potassium
Fasting glucose
Occurrence of adverse events potentially related to methylprednisolone
Survival
Radiological improvement
Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated

Full Information

First Posted
January 4, 2016
Last Updated
June 8, 2020
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02650609
Brief Title
Treatment of Chronic Subdural Hematoma by Corticosteroids
Acronym
SUCRE
Official Title
Treatment of Chronic Subdural Hematoma by Corticosteroids
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 24, 2016 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematomas
Keywords
chronic subdural hematomas, surgical treatment, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Quality of life score
Description
Short Form Health Survey 12 scale
Time Frame
1, 3 and 6 months
Title
Time to surgical treatment
Time Frame
during the first 6 months
Title
Rate of surgical treatment of the Chronic subdural hematomas
Time Frame
1, 3 and 6 months
Title
Functional scales : daily living
Description
Instrumental Activities of Daily Living scale
Time Frame
1, 3 and 6 months
Title
Functional scales : cognitive
Description
Mini-Mental State Examination scale
Time Frame
1, 3 and 6 months
Title
Functional scales : modified Rankin Scale
Description
modified Rankin Scale
Time Frame
1, 3 and 6 months
Title
Plasma sodium
Time Frame
day 0, 7, 14, and 21 and 1 month
Title
Potassium
Time Frame
day 0, 7, 14, and 21 and 1 month
Title
Fasting glucose
Time Frame
day 0, 7, 14, and 21 and 1 month
Title
Occurrence of adverse events potentially related to methylprednisolone
Time Frame
during the first 6 months
Title
Survival
Time Frame
6 months
Title
Radiological improvement
Description
Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier XM MORANDI, MD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Louis PH HENAUX, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Jean PL LE RESTE, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CHU Besançon
City
Besançon
Country
France
Facility Name
CHU Bordeaux Neurochirurgie A
City
Bordeaux
Country
France
Facility Name
CHU Bordeaux Neurochirurgie B
City
Bordeaux
Country
France
Facility Name
CHU Brest
City
Brest
Country
France
Facility Name
CHU Caen
City
Caen
Country
France
Facility Name
CHU Lille
City
Lille
Country
France
Facility Name
HC Lyon
City
Lyon
Country
France
Facility Name
AP-HM - Hôpital La Timone
City
Marseille
Country
France
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
CHU Saint Etienne
City
Saint Etienne
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU Tours
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28583162
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Chronic Subdural Hematoma by Corticosteroids

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