Clinical Trial: Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma: a Double-blind Randomized Controlled Pilot Study

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.


Detailed Summary:

Patients Recruitment for this single-center double-blind randomized placebo-controlled study was performed between January 2007 and May 2009. Patients were enrolled based on the following inclusion criteria: 18 years and older with evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging) and classified between 0 and 2 using the Markwalder grading scale (17) (Grade 0 for normal neurological status, grade 1 for no neurological deficits but mild symptoms, grade 2 for focal or variable neurological deficits, grade 3 for several focal neurological signs, and grade 4 for comatose). Exclusion criteria included contraindications or intolerance to corticosteroid therapy or 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 and refusal to participate in the study. If at any time, patients developed a sudden increase in hematoma volume, a midline displacement of greater than 1cm or a deterioration of their level of consciousness, they were removed from the conservative study protocol in order to undergo surgery.

This study was approved by the research ethics board at Centre Hospitalier Universitaire (CHU) de Quebec. Written and fully informed consent was obtained from each participant.

Randomization Allocation to each group was done in a 1:1 ratio with block sizes ranging from 4 to 6, to one of the two arms ; a treatment arm in which participants received dexamethasone according to the protocol, and a control group in which they received placebo. Randomization was performed via a web-based service by a pharmacist,
Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec

Current Primary Outcome: 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.


Original Primary Outcome: Rate of Need for Surgery Drainage [ Time Frame: Within 6 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire de Québec, CHU de Québec

Dates:
Date Received: February 9, 2015
Date Started: January 2007
Date Completion:
Last Updated: February 1, 2016
Last Verified: February 2016