Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial): study protocol for a randomised controlled trial

Abstract

Background: Chronic subdural haematoma (CSDH) is a common neurological disease with a rapidly rising incidence due to increasing age and widespread use of anticoagulants. Surgical intervention by burr-hole craniotomy (BHC) is the current standard practice for symptomatic patients, but associated with complications, a recurrence rate of up to 30% and increased mortality. Dexamethasone (DXM) therapy is, therefore, used as a non-surgical alternative but considered to achieve a lower success rate. Furthermore, the benefit of DXM therapy appears much more deliberate than the immediate relief from BHC. Lack of evidence and clinical equipoise among caregivers prompts the need for a head-to-head randomised controlled trial. The objective of this study is to compare the effect of primary DXM therapy versus primary BHC on functional outcome and cost-effectiveness in symptomatic patients with CSDH.

Methods/design: This study is a prospective, multicentre, randomised controlled trial (RCT). Consecutive patients with a CSDH with a Markwalder Grading Scale (MGS) grade 1 to 3 will be randomised to treatment with DXM or BHC. The DXM treatment scheme will be 16 mg DXM per day (8 mg twice daily, days 1 to 4) which is then halved every 3 days until a dosage of 0.5 mg a day on day 19 and stopped on day 20. If the treatment response is insufficient (i.e. persistent or progressive symptomatology due to insufficient haematoma resolution), additional surgery can be performed. The primary outcomes are the functional outcome by means of the modified Rankin Scale (mRS) score at 3 months and cost-effectiveness at 12 months. Secondary outcomes are quality of life at 3 and 12 months using the Short Form Health Survey (SF-36) and Quality of Life after Brain Injury Overall Scale (QOLIBRI), haematoma thickness after 2 weeks on follow-up computed tomography (CT), haematoma recurrence during the first 12 months, complications and drug-related adverse events, failure of therapy within 12 months after randomisation and requiring intervention, mortality during the first 3 and 12 months, duration of hospital stay and overall healthcare and productivity costs. To test non-inferiority of DXM therapy compared to BHC, 210 patients in each treatment arm are required (assumed adjusted common odds ratio DXM compared to BHC 1.15, limit for inferiority < 0.9). The aim is to include a total of 420 patients in 3 years with an enrolment rate of 60%.

Discussion: The present study should demonstrate whether treatment with DXM is as effective as BHC on functional outcome, at lower costs.

Trial registration: EUCTR 2015-001563-39 . Date of registration: 29 March 2015.

Keywords: BHC; Burr-hole craniostomy; CSDH; Chronic subdural haematoma; DXM; Dexamethasone.

Conflict of interest statement

Ethics approval and consent to participate

The study received approval by the Medical Ethics Committee (METC Zuid West Holland). This trial has been registered in the European Union Clinical Trials Register (EUCTR) and is conducted in compliance with the European Union Clinical Trials Directive (2001/20/EC) and the principles of the Declaration of Helsinki (2013).

For eligible patients, written informed has to be obtained by their treating physician. If a patient is not capable to give written informed consent (i.e. due to altered consciousness or aphasia), the treating physician will ask the legal representative to provide written informed consent. Once the patient is capable of giving their own informed consent, the treating physician (at the ward or outpatient clinic) will ask the patient to provide written informed consent. If the patient withdraws their permission, the patient data will not be used for this study.

Consent for publication

By giving written informed consent, patients agree with the storage of data and publication of the study results.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Time schedule of study procedures

Fig. 2

Flow diagram of main study procedures