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Open Access Study protocol

The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial

Stephan Emich1*, Bernd Richling2, Marc R McCoy3, Rahman Abdul Al-Schameri1, Feng Ling4, Liyong Sun4, Yabing Wang4 and Wolfgang Hitzl2

Author Affiliations

1 Christian Doppler Klinik, PMU Salzburg, Universitätsklinik für Neurochirurgie, Ignaz Harrer Str. 79, 5020 Salzburg, Austria

2 PMU Salzburg, Strubergasse 21, 5020 Salzburg, Austria

3 Christian Doppler Klinik, PMU Salzburg, Division Neuroradiologie, Universitätsklinik für Radiologie, Ignaz Harrer Str. 79, 5020 Salzburg, Austria

4 Department of Neurosurgery, Xuanwu Hospital, Capital Medical University Beijing, 45 Changchun Street, 100053 Beijing, PR China

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Trials 2014, 15:6  doi:10.1186/1745-6215-15-6

Published: 6 January 2014

Abstract

Background

Chronic subdural hematoma (cSDH) is a common neurosurgical disease. It is often considered to be a rather benign entity. In spite of well established surgical procedures cSDH is complicated by a recurrence rate up to 30%. Since glucocorticoids have been used for treatment of cSDH in 1962 their role is still discussed controversially in lack of evident data. On the basis of the ascertained inflammation cycle in cSDH dexamethasone will be an ideal substance for a short lasting, concomitant treatment protocol.

Objective: to test the efficacy of dexamethasone on reduction inthe reoperation rate of cSDH.

Methods/Design

The study is designed as a double-blind randomized placebo-controlled trial 820 patients who are operated for cSDH and from the age of 25 years are included after obtaining informed consent. They are randomized for administration of dexamethasone (16-16-12-12-8-4 mg/d) or placebo (maltodextrin) during the first 48 hours after surgery. The type I error is 5% and the type II error is 20%. The primary endpoint is the reoperation within 12 weeks postoperative.

Discussion

This study tests whether dexamethasone administered over 6 days is a safe and potent agent in relapse prevention for evacuated cSDH.

Trial registration

EudraCT 201100354442

Keywords:
Chronic; Subdural hematoma; Glucocorticoid; Dexamethasone; Therapy; Operative; Treatment