Treatment of Chronic Subdural Hematoma by Corticosteroids

Chronic Subdural Hematomas Clinical Trial

— SUCRE  

Official title:

Treatment of Chronic Subdural Hematoma by Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650609
• Other study ID #: 2015-000927-96
• Status: Completed
• Phase: Phase 3
• Start date: June 24, 2016
• Est. completion date: March 20, 2020

Study information

• Verified date: June 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Subdural Hematomas
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• Methylprednisolone

• Placebo

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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