- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01380028
Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas (hemacort)
Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas. Prospective Randomized Multicenter Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34090
- Gui de Chauliac Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,..)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
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
|
placebo
|
Active Comparator: oral corticosteroids
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
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the evaluation of efficacy of postoperative corticosteroid treatment in patients group compared with placebo
Time Frame: 6 months after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of mortality rate at one year
Time Frame: one year
|
Secondary objective is the evaluation of the effectiveness of corticosteroid treatment on the postoperative mortality rate at one year
|
one year
|
Evaluation of quality of life at one year
Time Frame: one year
|
Secondary objective is the evaluation of the effectiveness of corticosteroid treatment on the quality of life of patients
|
one year
|
evaluation of tolerance at one year
Time Frame: one year
|
Secondary objective is the evaluation of the tolerance of corticosteroid treatment at one year.
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lonjon Nicolas, MD,PhD, CHU de Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
- Hematoma, Subdural, Intracranial
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- 8545
- 2009-015524-28 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Intracranial Subdural Hematoma
-
Ospedale Policlinico San MartinoNot yet recruitingEndovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild SymptomsSubdural Hematoma, Chronic
-
Ataturk Training and Research HospitalCompletedSubdural Hematoma, ChronicTurkey
-
Balt USAAXIOM Real Time Metrics; Embo-Flüssigkeiten A.G.; Balt ExtrusionActive, not recruitingSubdural Hematoma, ChronicUnited States, France, Germany, Spain
-
Rennes University HospitalCompleted
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingChronic Subdural HematomasNetherlands
-
Huashan HospitalRecruitingChronic Subdural HematomaChina
-
The University of Texas Medical Branch, GalvestonNational Institute of Neurological Disorders and Stroke (NINDS)Not yet recruitingChronic Subdural HematomaUnited States
-
Chinese University of Hong KongWithdrawnChronic Subdural Hematoma | Subdural HematomaChina
-
Kwong Wah HospitalUnknownChronic Subdural Hematoma | Subdural DrainChina
-
University of Kansas Medical CenterNot yet recruiting
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States