drugset / Trial / NCT02362321

Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

NCT02362321 ↗

Phase 4 Terminated 20 enrolled CHU de Quebec-Universite Laval
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-01
Primary completion
2009-05
Completion
2009-05

Outcome

Outcome not reported

Stopped: “Due to serious adverse events”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 12 mg Oral

Indications

No indication recorded.