Are chronic subdural haematoma best treated with simple evacuation or evacuation and external drainage?
| ISRCTN | ISRCTN97314294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97314294 |
| Secondary identifying numbers | 04/Q0108/52 |
- Submission date
- 13/09/2005
- Registration date
- 26/07/2006
- Last edited
- 06/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr PJ Hutchinson
Scientific
Scientific
Box 167
Academic Neurosurgery Unit
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 245151 |
|---|---|
| pjah2@cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CaCSH trial |
| Study objectives | There is no difference in the recurrence of chronic subdural haematomas (CSDH) regardless of whether post-operative drainage or no drainage is used. |
| Ethics approval(s) | Approved by the Cambridge Local Ethics Research Committee in October 2004, reference number: 04/Q0108/52 |
| Health condition(s) or problem(s) studied | Chronic subdural haematoma (CSDH) |
| Intervention | Closed subdural-to-external drainage for 48 hours after completion of a standard burr hole evacuation of the CSDH evacuation versus burr holes and drainage with no external drain |
| Intervention type | Other |
| Primary outcome measure | Recurrence rate after drainage of CSDH as measured by re-operations |
| Secondary outcome measures | 1. Operative complications 2. Medical complications 3. Length of hospitalisation 4. Neurological status and modified Rankin scale at discharge and at three-months follow up |
| Overall study start date | 01/11/2004 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 subjects in either arm |
| Key inclusion criteria | Symptomatic chronic subdural haematoma in adult patients |
| Key exclusion criteria | 1. Patients younger than 18 years 2. Treatment other than burrhole required (e.g. craniotomy) 3. Drainage of an ipsilateral CSDH within preceding six months |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box 167
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Addenbrooke's Hospital, Cambridge University Hospitals (UK)
Government
Government
Box 166
Academic Department of Neurosurgery
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
"ROR" |
https://ror.org/055vbxf86 |
|---|
Funders
Funder type
Hospital/treatment centre
Addenbrooke's Hospital, Cambridge University Hospitals (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/09/2009 | Yes | No |
