Clinical trial NCT02650609: Treatment of Chronic Subdural Hematoma by Corticosteroids
Official title: Treatment of Chronic Subdural Hematoma by Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Subdural Hematomas
Keywords: chronic subdural hematomas
surgical treatment
corticosteroids
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Delay of occurrence of surgical treatment of the Chronic subdural hematomas
timeFrame: 1 month
Secondary outcomes:
measure: Quality of life score
timeFrame: 1, 3 and 6 months
measure: Time to surgical treatment
timeFrame: during the first 6 months
measure: Rate of surgical treatment of the Chronic subdural hematomas
timeFrame: 1, 3 and 6 months
measure: Functional scales : daily living
timeFrame: 1, 3 and 6 months
measure: Functional scales : cognitive
timeFrame: 1, 3 and 6 months
measure: Functional scales : modified Rankin Scale
timeFrame: 1, 3 and 6 months
measure: Plasma sodium
timeFrame: day 0, 7, 14, and 21 and 1 month
measure: Potassium
timeFrame: day 0, 7, 14, and 21 and 1 month
measure: Fasting glucose
timeFrame: day 0, 7, 14, and 21 and 1 month
measure: Occurrence of adverse events potentially related to methylprednisolone
timeFrame: during the first 6 months
measure: Survival
timeFrame: 6 months
measure: Radiological improvement
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux Neurochirurgie A
city: Bordeaux
country: France
facility: CHU Bordeaux Neurochirurgie B
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: HC Lyon
city: Marseille
country: France
facility: AP-HM - Hôpital La Timone
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Poitiers
country: France
facility: CHU Poitiers
city: Rouen
country: France
facility: CHU Rouen
city: Saint Etienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHU Rennes
name: Xavier XM MORANDI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Pierre-Louis PH HENAUX, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Pierre-Jean PL LE RESTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.