Abstract
Background
Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.
Methods
Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.
Discussion
This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.
Trial registration
ISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015.
Dex-CSDH trial protocol version 3, 27 Apr 2017.
This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.
Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.
Methods
Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.
Discussion
This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.
Trial registration
ISRCTN, ISRCTN80782810. Registered on 7 November 2014. EudraCT, 2014-004948-35. Registered on 20 March 2015.
Dex-CSDH trial protocol version 3, 27 Apr 2017.
This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.
| Original language | English |
|---|---|
| Article number | 670 |
| Number of pages | 14 |
| Journal | Trials |
| Volume | 19 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 4 Dec 2018 |
Bibliographical note
AcknowledgementsThe following individuals should be indexed on PubMed as collaborators
BNTRC collaborators: Khaled Badran, Ian Coulter, Mathew J Gallagher, Florence
RA Hogg, Catherine Pringle, Adam Razak, Hamzah Soleiman, Rory Piper, Emma
Toman, Marian Vintu, Adam Wahba, Anthony Wiggins, Kamal Makram Yakoub,
Malik Zaben, Ardalan Zolnouria.
Dex-CSDH trial collaborators: Peter Bodkin, Emanuel Cirstea, Giles Critchley,
Charlotte Eglinton, Louise Finlay, Daniela Georgieva, Nihal Gurusinghe,
Nikolaos Haliasos, Damian Holliman, Kismet Hossain-Ibrahim, Masood
Hussain, Jothy Kandasamy, Mary Kambafwile, Phillip Kane, Dipankar Nandi,
Ravindra Nannapaneni, Laura Ortiz-Ruiz de Gordoa, Marios C Papadopoulos,
Dimitris Paraskevopoulos, Jash Patel, Manjunath Prasad, Nikolaos Tzerakis.
Protocol contributors: Carol Brayne, Andrew Gardner, Andrew King, Kate
Massey, Thais Minett, Patrick Mitchell, Phyo Myint, Elizabeth Warburton.
TSC members: Professor Anthony Bell (Chair), Allison Hirst, Laurence Watkins,
Peter McCabe.
IDMEC members: Martin Smith (Chair), Joan Grieve, Jonathan Cook
Funding
This research was funded by the National Institute for Health Research Health
Technology Assessment programme (NIHR HTA), project number 13/15/02.
E Edlmann has received funding from the Royal College of Surgeons, Rosetrees
Trust Research Fellowship.
E Thelin is funded by post-doc stipends from the Swedish Society for Medical
Research.
PJH is supported by a Research Professorship from the National Institute for
Health Research (NIHR) and by the NIHR Biomedical Research Centre, Cambridge.
Keywords
- chronic subdural haematoma
- dexamethasone
- neurosurgery
- neurology
- randomised control trial