search
Back to results

Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

Primary Purpose

Hematoma, Subdural, Chronic

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematoma, Subdural, Chronic focused on measuring [C10.228.140.300.535.450.400.120]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Dexamethasone

    Control

    Arm Description

    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).

    Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.

    Outcomes

    Primary Outcome Measures

    Rate of Need for Surgery Drainage
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2015
    Last Updated
    February 1, 2016
    Sponsor
    CHU de Quebec-Universite Laval
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02362321
    Brief Title
    Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma
    Official Title
    Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma: a Double-blind Randomized Controlled Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    Due to serious adverse events
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CHU de Quebec-Universite Laval

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 Description
    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, which was not involved in any other part of the study. Both investigators and participants were blind to treatment allocation. Treatment 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). Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days. Participants were returned at home with blister packs containing their medication for each day of the trial and were asked to return empty packs to ensure compliance with the assigned treatment. The treatment (placebo or dexamethasone) was discontinued if a patient required surgical drainage of its hematoma or suffered from significant side effects. Evaluation and follow-up The primary outcome of this pilot study was to determine the efficacy of dexamethasone as compared with placebo in reducing the rate of surgical intervention for CSDH graded 0 to 2 on the Markwalder grading scale (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). Eligible patients who consented for the study underwent the routine standard of care. This included 1) a complete medical history review and neurological physical exam ; 2) head computerized tomography (CT) or MRI with measurement of maximal hematoma thickness (in mm), midline shift ; 3) and a check of blood and vital parameters. In addition, patients were asked to complete detailed questionnaires measuring symptoms typically associated with subdural hematomas. Follow-up appointments were scheduled 2 weeks, 1, 2 and 6 months after initiation of treatment. At each visit, the three components of the clinical evaluation described above were repeated. Moreover, a seven point categorical scale was used to evaluate patient's global impression of change relative to the initial state (unchanged , very much improved, much improved, minimally improved, minimally worse, much worse, very much worse). Treatment-related side effects were also inquired about and collected. The rate of success of conservative management was defined as the percentage of patients not requiring surgery in each treatment group during the 6 months following enrollment. Radiological progression of the hematoma in terms of thickness and magnitude of midline shift, hematoma-related symptoms and medication-related side effects were carefully collected. Statistical analyses Demographical characteristics, baseline neurological status and hematoma size and location were compared for both groups using a Mann-Whitney test for continuous variable and a χ2 test for categorical variables. To compare the rate of success, a categorical frequency comparison with the Fisher's exact test was used. For the other outcome measures we used Mann-Whitney U test and Student's t-test for normally distributed variables and χ2 or Fisher's exact test for categorical frequencies. All statistical tests were done with the Statistical package for Social Sciences software version 16.0 and the significance threshold was set at p<0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematoma, Subdural, Chronic
    Keywords
    [C10.228.140.300.535.450.400.120]

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    Corticosteroid, Decadron
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
    Primary Outcome Measure Information:
    Title
    Rate of Need for Surgery Drainage
    Description
    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.
    Time Frame
    Within 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

    We'll reach out to this number within 24 hrs