Treatment of Chronic Subdural Hematoma by Corticosteroids (SUCRE)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Subdural Hematomas
• Intervention / Treatment: Drug: Placebo; Drug: Methylprednisolone

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 Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Methylprednisolone
Placebo Comparator: 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.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Delay of occurrence of surgical treatment of the Chronic subdural hematomas	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Xavier XM MORANDI, MD, PhD, CHU Rennes; Principal Investigator: Pierre-Louis PH HENAUX, MD, CHU Rennes; Principal Investigator: Pierre-Jean PL LE RESTE, MD, CHU Rennes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2016
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: corticosteroids; surgical treatment; chronic subdural hematomas
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 2015-000927-96

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No