Are chronic subdural haematoma best treated with simple evacuation or evacuation and external drainage?

ISRCTN	ISRCTN97314294
DOI	https://doi.org/10.1186/ISRCTN97314294
Protocol serial number	04/Q0108/52
Sponsor	Addenbrooke's Hospital, Cambridge University Hospitals (UK)
Funder	Addenbrooke's Hospital, Cambridge University Hospitals (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr PJ Hutchinson
Scientific

Box 167
Academic Neurosurgery Unit
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 245151
Email	pjah2@cam.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Recurrence rate after drainage of CSDH as measured by re-operations
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
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

Box 167

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/09/2009		Yes	No