Dex - CSDH Trial
Research type
Research Study
Full title
A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma.
IRAS ID
168748
Contact name
Peter Hutchinson
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2014-004948-35
ISRCTN Number
ISRCTN80782810
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This study aims to look at whether a two-week course of dexamethasone can improve mortality and functional outcome in patients with chronic Subdural Haematomas (cSDH).
CSDH is a common neurosurgical pathology, affecting 5000 people aged over 65 in the UK each year. It is often related to a relatively minor head injury and result in a collection of blood overlying the surface of the brain. This collection can progress, leading to increased pressure in the head and subsequent neurological deficits, drowsiness and ultimately coma. Many patients require an operation to drain the collection. This often means exposing elderly patients, potentially with a large number of co-morbidities to an anaesthetic and the inherent risks associated. In addition, the cSDH can recollect and require subsequent further drainage in up to 20% of patients.
Although not fully understood, the underlying pathology of cSDH is suspected to involve an inflammatory process. Therefore recent studies have assessed the role of steroids as an anti-inflammatory in this condition. They have been shown to reduce the recurrence rate of cSDH and we hypothesise that they could therefore reduce mortality and morbidity from cSDH and negate the need for surgery in some patients.
We plan to recruit 750 patients with a diagnosis of cSDH from neurosurgical units within the United Kingdom. Patients will be randomised to receive either dexamethasone or a placebo for 14 days.
The main outcome measure will be the modified Rankin Scale (mRS) at 6 months, a measure of the patients independence and function. Other outcomes measured will include the clinical pathway of the patient, recurrence rate of cSDH, length of stay in hospital, discharge destination, any adverse events or complications and mortality. Finally we will be assessing degree of morbidity using several questionnaires focused on quality of life, independence and disability.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0171
Date of REC Opinion
19 Mar 2015
REC opinion
Favourable Opinion