A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic Chronic Subdural Haematoma (Dex-CSDH trial)
| ISRCTN | ISRCTN80782810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80782810 |
| EudraCT/CTIS number | 2014-004948-35 |
| Secondary identifying numbers | HTA 13/15/02 |
- Submission date
- 07/11/2014
- Registration date
- 07/08/2015
- Last edited
- 18/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Chronic subdural haematoma (CSDH) is a collection of liquefied blood between the surface of the brain and its outmost lining. It is especially common in older individuals and can happen with only a minor injury to the head. It can cause drowsiness, confusion, limb weakness and problems with mobility. In the UK, 5,000 people aged over 65 years are diagnosed with a CSDH each year. In the NHS, patients with severe symptoms usually undergo an operation to evacuate the CSDH. Patients with milder symptoms are usually actively monitored. Although about 80-85% of the patients tend to recover well from this operation, approximately 15-20% of patients will have a recurrence of the CSDH and require a further operation. This significantly reduces the chances of good recovery. A considerable body of evidence suggests that steroids can reduce the rate of recurrence and, in some cases, avoid the need for surgery altogether. However, steroids have side effects and it is not known whether the benefits outweigh the risks in this context. Currently, there is no high-quality evidence showing whether steroids should be used routinely for patients with CSDH. The Dex-CSDH study will provide this much needed evidence. The Dex-CSDH study will focus on symptomatic patients with CSDH and will compare the use of steroids against placebo ('dummy' treatment).
Who can participate?
All patients admitted to a participating neurosurgical unit with a CSDH will be considered for the study based on pre-specified criteria.
What does the study involve?
Once consent is in place, you will be assigned randomly (like the flip of a coin) to take either dexamethasone or placebo. The latter is sometimes called the ‘dummy capsule’. It looks the same as the active treatment (dexamethasone) but does not contain any of the active ingredients. The treatment (dexamethasone or placebo) will be administered daily for 14 days on a tapering course, which reduces the dose over the 14-day study period. Neither you nor your doctor will know which treatment you are receiving – this is necessary in order to draw valid conclusions at the end of the study. Before you leave the hospital we will assess your level of recovery. We will also ask you to fill in a short questionnaire pack at 3 and 6 months after leaving the hospital, as we would like to find out about your recovery and state of health.
What are the possible benefits and risks of participating?
There is no guaranteed benefit from taking part in this study. However, information collected in the study may benefit patients with a subdural haematoma in the future. Apart from the potential side effects of dexamethasone, there are no additional risks or disadvantages involved with taking part in this study. Dexamethasone is a medication used regularly in the treatment of many medical conditions. It is also widely used in many patients with conditions affecting the nervous system, e.g. brain tumours. The side effects of dexamethasone are rare with a short course such as the one in this study. You will continue to receive the standard care for your condition.
Where is the study run from?
The study is run from the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. It is expected that the majority of UK neurosurgical centres will participate.
When is the study starting and how long is it expected to run for?
September 2014 to August 2019 (updated 09/06/2020, previously: May 2020 (as of 04/10/2018))
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).
Who is the main contact?
Prof Peter Hutchinson – Chief Investigator
neurosurgsec@medschl.cam.ac.uk
Mr Angelos Kolias – Co-Chief Investigator
angeloskolias@gmail.com
Contact information
Scientific
University of Cambridge
Dept of Clinical Neurosciences
Division of Neurosurgery
Box 167
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom
 ORCID ID |
0000-0002-2796-1835 |
|---|---|
| neurosurgsec@medschl.cam.ac.uk |
Public
Cambridge Clinical Trials Unit
Coton House
Level 6
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 254921 |
|---|---|
| carol.daviswilkie@addenbrookes.nhs.uk |
Scientific
Department of Clinical Neurosciences
Division of Neurosurgery
Box 167
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| eedlmann@nhs.net |
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised, double blind, placebo-controlled trial of a two-week course of dexamethasone for adult patients with a symptomatic Chronic Subdural Haematoma (Dex-CSDH trial) |
| Study acronym | Dex CSDH |
| Study hypothesis | Dexamethasone can improve the functional outcome of patients with symptomatic chronic subdural haematomas by reducing the rate of surgical intervention and the recurrence rate. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/131502 |
| Ethics approval(s) | NRES Committee North West - Haydock, 14/04/2015, REC ref: 15/NW/0171 |
| Condition | Chronic subdural haematoma CSDH |
| Intervention | Patients will be randomized to take either dexamethasone or a placebo. The treatment will be administered daily for up to 14 days on a tapering course, which reduces the dose over the study period. The study period lasts for 6 months. At 3 months and again at 6 months short questionnaires will be completed, either face to face, by post or via telephone, to assess level of recovery. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dexamethasone |
| Primary outcome measure | Modified Rankin Scale (mRS) at 6 months post-randomisation |
| Secondary outcome measures | Current secondary outcome measures as of 26/08/2020: Measured using patient records unless noted otherwise: 1. Number of CSDH-related surgical interventions undertaken during the index admission 2. Number of CSDH-related surgical interventions undertaken during subsequent admissions in the follow-up period 3. Glasgow Coma Scale (GCS) at discharge from NSU and at 6 months 4. mRS score at discharge from NSU and at 3 months 5. Barthel Index at discharge from NSU, 3 months and 6 months 6. Mortality (30-day and 6 months) 7. EuroQOL (EQ-5D) at discharge from NSU, 3 months and 6 months 8. Length of stay in NSU 9. Discharge destination from NSU 10. Length of stay in secondary care 11. Health-economic analysis 12. Adverse Events (added 21/09/2020) 13. Post-operative recurrence is a tertiary outcome measure and is defined as a symptomatic recurrence requiring re-operation of a previously evacuated ipsilateral chronic subdural hematoma Previous secondary outcome measures: 1. Rate of cSDH-related surgical interventions undertaken during the index admission 2. Rate of cSDH-related surgical interventions undertaken during subsequent admissions 3. Glasgow Coma Scale (GCS) at discharge from NSU and 6 months 4. mRS score at discharge from NSU and 3 months 5. Barthel Index at discharge from NSU, 3 months and 6 months 6. Mortality (30-day and 6 months) |
| Overall study start date | 01/05/2015 |
| Overall study end date | 29/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 750 |
| Total final enrolment | 748 |
| Participant inclusion criteria | 1. Informed consent 2. Adults aged 16 or older 3. Symptomatic cSDH confirmed on cranial imaging (predominantly hypodense or isodense crescentic collection along the cerebral convexity on CT) |
| Participant exclusion criteria | 1. Patients who have already undergone surgical intervention for a cSDH during the same index admission 2. Condition with conditions where steroids are clearly contra-indicated (i.e. active infections) 3. Already on steroids 4. Enrolment in same study within last 12 months 5. Time interval from the time of admission to NSU to initiation of trial medication exceeds 72 hours 6. cSDH in presence of CSF shunt |
| Recruitment start date | 11/08/2015 |
| Recruitment end date | 24/11/2018 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
United Kingdom
United Kingdom
NE7 7DN
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
United Kingdom
United Kingdom
Glasgow
G51 4TF
United Kingdom
Great George Street
Leeds
LS1 3EX
United Kingdom
Glossop Road
Sheffield
S10 2JF
United Kingdom
BN2 1ES
United Kingdom
TS4 3BW
United Kingdom
ST4 6QG
United Kingdom
SW17 0QT
United Kingdom
HU3 2JZ
United Kingdom
EH4 2XU
United Kingdom
E1 1FR
United Kingdom
AB25 2ZN
United Kingdom
PR2 9HT
United Kingdom
RM7 0AG
United Kingdom
OX3 9DU
United Kingdom
DD2 1SG
United Kingdom
CF14 4XW
United Kingdom
M6 8HD
United Kingdom
Sponsor information
Hospital/treatment centre
Box 277
Addenbrookes Hospital
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| clt29@medschl.cam.ac.uk | |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We intend to disseminate the findings of the Dex-CSDH trial via medical journals, the HTA journal and presentations at national and international meetings. In addition, research findings will be disseminated to relevant service user groups and charities through newsletters, website posts and public presentations. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/12/2018 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 10/12/2019 | 12/12/2019 | No | No |
| Results article | results | 31/12/2020 | 17/12/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/03/2024 | 18/09/2024 | Yes | No |
Editorial Notes
18/09/2024: Publication reference added.
17/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
21/09/2020: The secondary outcome measures were changed.
26/08/2020: The secondary outcome measures were changed.
09/06/2020: The following changes were made to the trial record:
1. The trial website was added.
2. The trial participating centre "Newcastle Hospitals NHS Foundation Trust" was changed to "Royal Victoria Infirmary".
3. The overall end date was changed from 01/05/2020 to 29/08/2019.
4. The condition was changed from Head injury to Chronic subdural haematoma CSDH.
5. The recruitment end date was changed from 28/08/2019 to 24/11/2018.
6. The trial participating centres "Queen Elizabeth University Hospital, Leeds General Infirmary, Royal Hallamshire Hospital, Brighton and Sussex University Hospital, James Cook University Hospital, Royal Stoke University Hospital, St Georges University Hospitals, Hull Royal Infirmary, Western General Hospital, Royal London Hospital, Aberdeen Royal Infirmary, Royal Preston Hospital, Queen's Hospital, John Radcliffe Hospital, Ninewells Hospital, University Hospitals of Wales, Salford Royal NHS Foundation Trust" were added.
7. The intention to publish date was changed from 01/05/2021 to 31/12/2020.
8. The participant level data was changed from "Available on request" to "Not expected to be available"
12/12/2019: Publication reference added.
03/09/2019: Internal review.
10/12/2018: Publication reference added.
04/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 01/05/2019 to 01/05/2020
2. The recruitment end date has been changed from 28/08/2018 to 28/08/2019
3. The plain English summary has been updated
4. The intention to publish date has been changed from 01/09/2019 to 01/05/2021
