Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/09/2005
Date assigned
26/07/2006
Last edited
06/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Addenbrooke's Hospital, Cambridge University Hospitals (UK)

Sponsor details

Box 166
Academic Department of Neurosurgery
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19782872

Publication citations

  1. 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.

Additional files

Editorial Notes