Treatment of Chronic Subdural Hematoma by Corticosteroids

Phase 3

Completed

• Conditions: Chronic Subdural Hematomas
• Interventions: Drug: Placebo; Drug: Methylprednisolone

• Registration Number: NCT02650609
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Study Start: 2016-06-24
• Primary Completion: 2019-03-20
• Study Completion: 2020-03-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Methylprednisolone	Methylprednisolone	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.

Primary Outcome Measures

Name	Time	Method
Delay of occurrence of surgical treatment of the Chronic subdural hematomas	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (17)

CHU Bordeaux Neurochirurgie B; 🇫🇷 Bordeaux, France

CHU Amiens; 🇫🇷 Amiens, France

CHU Lille; 🇫🇷 Lille, France

CHU Besançon; 🇫🇷 Besançon, France

CHU Tours; 🇫🇷 Tours, France

CHU Angers; 🇫🇷 Angers, France

CHU Brest; 🇫🇷 Brest, France

AP-HM - Hôpital La Timone; 🇫🇷 Marseille, France

CHU Bordeaux Neurochirurgie A; 🇫🇷 Bordeaux, France

HC Lyon; 🇫🇷 Lyon, France

CHU Caen; 🇫🇷 Caen, 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