Treatment of chronic subdural hematoma by corticosteroids : a prospective randomized study

Treatment of chronic subdural hematoma by corticosteroids : a prospective randomized study - Morandi SUCRE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000927-96-FR

Enrollment

226

Registered

2015-07-23

Start date

2015-08-04

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic subdural hematoma MedDRA version: 18.0 Level: LLT Classification code 10049163 Term: Chronic subdural hematoma System Organ Class: 100000004863

Interventions

Product Name: methylprednisolne Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral us

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Age = 18 years old -With chronic or subacute, uni- or bilateral subdural hematoma -Confirmed by cerebral CT scan without contrast enhancement -Without clinical and radiological signs of severity -Written informed consent from patients or thier next of kin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Contraindication for methylprednisolone -Previous surgery for chronic subdural hematoma during the past 6 months -Pre-existing severe dementia -Existing neurological pathology that can be associated with dementia -Patients treated with corticosteroids -Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty

Design outcomes

Primary

Measure	Time frame
Main Objective: show that a treatment with methylprednisolone can decrease the need for surgical treatment in patients with chronic subdural hematoma without clinical or radiological signs of severity; Secondary Objective: assess the effect of methylprednisolone on : -quality of life evolution -morbidity and mortality -radiological evolution of the lesions ;Primary end point(s): rate of surgical treatment of the chronic subdural hematoma;Timepoint(s) of evaluation of this end point: at one month	—

Measure

Time frame

Main Objective: show that a treatment with methylprednisolone can decrease the need for surgical treatment in patients with chronic subdural hematoma without clinical or radiological signs of severity; Secondary Objective: assess the effect of methylprednisolone on : -quality of life evolution -morbidity and mortality -radiological evolution of the lesions ;Primary end point(s): rate of surgical treatment of the chronic subdural hematoma;Timepoint(s) of evaluation of this end point: at one month

—

Secondary

Measure	Time frame
Secondary end point(s): -Quality of life assessed by the SF 12 scale -Time to surgical treatment -Functional scales : daily living, cognitive and modified Rankin Scale -Plasma sodium, potassium and fasting glucose -Occurrence of adverse events potentially related to methylprednisolone -Survival -Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated ; Timepoint(s) of evaluation of this end point: -Quality of life assessed by the SF 12 scale at 1, 3 and 6 months -Time to surgical treatment at 6 months -Functional scales at 1, 3 and 6 months -Plasma sodium, potassium and fasting glucose at day 0, 7, 14, and 21 and at 1 month -Occurrence of adverse events potentially related to methylprednisolone at 6 months -Survival at 6 months -Radiological improvement at 1, 3 and 6 months	—

Measure

Time frame

Secondary end point(s): -Quality of life assessed by the SF 12 scale -Time to surgical treatment -Functional scales : daily living, cognitive and modified Rankin Scale -Plasma sodium, potassium and fasting glucose -Occurrence of adverse events potentially related to methylprednisolone -Survival -Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated ; Timepoint(s) of evaluation of this end point: -Quality of life assessed by the SF 12 scale at 1, 3 and 6 months -Time to surgical treatment at 6 months -Functional scales at 1, 3 and 6 months -Plasma sodium, potassium and fasting glucose at day 0, 7, 14, and 21 and at 1 month -Occurrence of adverse events potentially related to methylprednisolone at 6 months -Survival at 6 months -Radiological improvement at 1, 3 and 6 months

—

Countries

France

Contacts

Public ContactGanivet

CHU of Rennes

anne.ganivet@chu-rennes.fr33299282555

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026