Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

NCT02362321 | Terminated Phase 4 Results DMC

• 1 other identifier: PEJ-370
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematoma, Subdural, Chronic

Keywords

[C10.228.140.300.535.450.400.120]

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 6 months

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Dexamethasone DRUG

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).

Also known as: Corticosteroid, Decadron

Dexamethasone

Placebo OTHER

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

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Dexamethasone; Adrenal Cortex Hormones; Calcium Dobesilate

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Principal Investigator
• Organization: CHU de Québec

michel.prudhomme.chuq@gmail.com

418-649-0252

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 12, 2015
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 29, 2016
• Results First Posted: February 27, 2015

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share