Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas

NCT01380028 | Terminated Phase 3

• 2 other identifiers: 85452009-015524-28
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

The chronic subdural hematoma is a common disease in the population over 60 years. For example, in patients over 70 years, it occurs every year 7 new cases per 100,000 people. A chronic subdural hematoma is an accumulation of blood in the intracranial space between brain membrane (dura mater) and the brain. The origin of blood in this area follows a minor brain injury, which causes the rupture of small vessels in the area. During its evolution, the volume of the hematoma increases. After a few weeks, the amount of fluid build-up can compress the brain. That's when clinical symptoms occur: persistent headaches, neurological deficits, seizures, impaired consciousness, cognitive functions (memory loss, impaired intellectual function, or hallucinations, etc.). The compression of the brain may cause impairment of consciousness resulting in more severe cases coma and death. At this stage, a neurosurgical intervention is necessary. Recurrences are numerous (15 to 25% recurrence over six months after neurosurgery). That is why in France, about 20% of medical teams administer a postoperative treatment with corticosteroids to reduce the risk of recurrence. Until now, the potential benefit of this treatment has not yet been confirmed by a clinical study. So the purpose of this research.

Conditions

Chronic Intracranial Subdural Hematoma

Keywords

chronic subdural hematomas; corticosteroid; treatment; neurosurgery; recurrence, adjuvant

Outcome Measures

Primary Outcomes (1)

• the evaluation of efficacy of postoperative corticosteroid treatment in patients group compared with placebo

  The objective of this study is to evaluate in patients with chronic subdural hematoma, compared with placebo, the efficacy of postoperative corticosteroid treatment orally for about two months on the rate of clinical recurrence and / radiological or subdural hematoma 6 months after surgery (primary endpoint).

  6 months after surgery

Secondary Outcomes (3)

• Evaluation of mortality rate at one year

  one year

• Evaluation of quality of life at one year

  one year

• evaluation of tolerance at one year

  one year

Study Arms (2)

placebo

PLACEBO COMPARATOR

The aim of this prospective multicenter randomized, double blind, is to evaluate in patients with chronic subdural hematoma, compared with placebo, the efficacy of postoperative corticosteroid treatment orally for approximately 2 months on the rate of clinical recurrence

Drug: placebo

oral corticosteroids

ACTIVE COMPARATOR

The aim of this prospective multicenter randomized, double blind, is to evaluate in patients with chronic subdural hematoma, compared with placebo, the efficacy of postoperative corticosteroid treatment orally for approximately 2 months on the rate of clinical recurrence

Drug: oral corticosteroids

Interventions

oral corticosteroids DRUG

Active treatment is prednisone establishment within 72 hours after the end of surgery at the dose of 1 mg / kg (rounded to the nearest 10 mg) once daily orally for one week . The daily dose then decreases in increments of 10 mg weekly, by the second week. Once the level of 10 mg / day reached the daily dose by one level lower than 5 mg weekly. Treatment is stopped after this week to 5 mg / day (average 2 months of treatment)

Also known as: Cortancyl

oral corticosteroids

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes operated for chronic subdural hematoma one-sided or bilateral of firstly diagnosis, after consultation in neurosurgery for a symptomatology in touch with this hematic collection.
• At the End of the surgical operation \< 72 hours
• Hematoma must be hypodense or isodense. He has to present a value \< 50 on the scale of Hounsfield measured in the center of the collection on the initial intellectual scanning, this measure not in front of not to be made on a zone of new bleeding treble or on a membrane (in case of compartmentalized hematoma).
• The blade of the hematoma has to measure at least 3 mm in thickness on an axial cutting.

You may not qualify if:

• Age \< 18 years
• Weight \> 104 kg
• Histories of hematoma chronic subdural for which a medical and\\or surgical treatment were before realized
• Patient Presenting:
• uncontrolled arterial hypertension, current Infection, Diabetes treated by drugs, Ulcer evolutionary gastroduodenal in the course of treatment and dating \< 6 months, turned out Osteoporosis symptomatic of cortisone origin, uncontrolled psychotic State by a treatment, except the sultopride, ulcerous Colitis, recent intestinal Anastomose, Renal insufficiency, hepatic Incapacity, Hypercalcemia,Hypercalciuria,calcic Lithiasis, high sensibility at drug'study, Intolerance: galactose, fructose, deficit in lactase, syndrome of malabsorption of glucose or galactose
• Clinical or radiological Characteristics of hematoma suspecting an intra-cranial infection (abscess,..)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Marseille: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Hospices Civils de Lyon: collaborator
• Centre hospitalier de Perpignan: collaborator

Study Sites (1)

Gui de Chauliac Hospital

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Interventions

Adrenal Cortex Hormones; Prednisone

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lonjon Nicolas, MD,PhD

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 27, 2011
• Study Start: July 22, 2011
• Primary Completion: September 12, 2014
• Study Completion: September 12, 2014
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

FR (1)