Contact information
Type
Scientific
Primary contact
Mr PJ Hutchinson
ORCID ID
Contact details
Box 167
Academic Neurosurgery Unit
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 245151
pjah2@cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/Q0108/52
Study information
Scientific title
Acronym
CaCSH trial
Study hypothesis
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
Approved by the Cambridge Local Ethics Research Committee in October 2004, reference number: 04/Q0108/52
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/11/2004
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Symptomatic chronic subdural haematoma in adult patients
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 subjects in either arm
Participant 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
Recruitment start date
01/11/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Box 167
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Addenbrooke's Hospital, Cambridge University Hospitals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19782872
Publication citations
-
Results
Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ, Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial., Lancet, 2009, 374, 9695, 1067-1073, doi: 10.1016/S0140-6736(09)61115-6.