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Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

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ClinicalTrials.gov Identifier: NCT02362321
Recruitment Status : Terminated (Due to serious adverse events)
First Posted : February 12, 2015
Results First Posted : February 27, 2015
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Brief Summary:

Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas are mostly based on observational studies. Here we present data from a prospective randomized pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or placebo for 30 days.

Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed CSDH were recruited from a single center and randomized in order to receive dexamethasone or placebo as a conservative treatment. Patients affected to the treatment group received oral dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for 6 months and the rate of success of conservative treatment versus placebo was measured. Parameters such as hematoma thickness and global impression of change were also compared before and after treatment with chi-square tests. Adverse events and complications were documented.


Condition or disease Intervention/treatment Phase
Hematoma, Subdural, Chronic Drug: Dexamethasone Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma: a Double-blind Randomized Controlled Pilot Study
Study Start Date : January 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexamethasone
Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).
Drug: Dexamethasone
Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).
Other Names:
  • Corticosteroid
  • Decadron

Placebo Comparator: Control
Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
Other: Placebo
Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.




Primary Outcome Measures :
  1. Rate of Need for Surgery Drainage [ Time Frame: Within 6 months ]
    The rate of success of conservative management was defined as the number of patients not requiring surgery in each treatment group during the 6 months following enrollment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging)
  • classified between 0 and 2 using the Markwalder grading scale

Exclusion Criteria:

  • contraindications or intolerance to corticosteroid therapy
  • patients already undergoing steroid treatment for any other indication
  • previous neurological surgery up to one year prior to being considered for the study
  • concomitant cerebral pathology of neoplastic or presumed infectious origin
  • anticoagulant therapy that could not be stopped for 6 months
  • refusal to participate in the study

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Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02362321    
Other Study ID Numbers: PEJ-370
First Posted: February 12, 2015    Key Record Dates
Results First Posted: February 27, 2015
Last Update Posted: February 29, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by CHU de Quebec-Universite Laval:
[C10.228.140.300.535.450.400.120]
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
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
Wounds and Injuries
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents