Contact information
Type
Scientific
Primary contact
Ms Bridget Colam
ORCID ID
Contact details
Neurosciences Trials Unit
Bramwell Dott Building
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 537 2930
gala@skull.dcn.ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2268/1979
Study information
Scientific title
Acronym
GALA
Study hypothesis
A prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy is proposed to determine whether the type of anaesthesia does indeed influence peri-operative morbidity and mortality, quality of life and long term outcome in terms of stroke-free survival.
Please note that as of 29/05/2008 this record was updated to include a longer recruitment period. All changes can be found under the relevant fields, with the update date of 29/05/2008. The anticipated end date of this trial was extended to 30/04/2008. The previous anticipated end date of this trial was 31/12/2006. Randomisation stopped on 31/10/2007 and the presentation of results is expected on 06/09/08.
Ethics approval
Ethics approval received from the Northern and Yorkshire MREC on the 28th August 1998 (pilot phase) and 22nd April 2003 (main phase).
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
Carotid stenosis (at risk from stroke)
Intervention
Anaesthetic for surgery - local versus general. Randomisation will be by telephone to the trial office. Data will be collected at baseline (prior to randomisation) and this will include demographic details, known risk factors, diagnostic procedures and findings, and indications for surgery. The follow-up data will be collected when the patient is discharged from acute care, and operative details and any early complications will be recorded. At 1 month post-surgery, a stroke physician, blind to the type of anaesthesia, will review the patient. Also the patient will be asked to complete a health related quality of life questionnaire including the widely used EuroQol and Short Form 36, plus a carotid endarterectomy (CEA) specific questionnaire designed to capture patient satisfaction levels with the method of anaesthesia. Length of time spent in the recovery room, intensive care unit (ICU) and high dependency unit (HDU), and length of overall acute hospital stay will be recorded. Annual follow up will be by post to the family doctor and to the patient, seeking details of any strokes.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
The proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction (MI) 30 days post-surgery.
Secondary outcome measures
Proportion alive and stroke free at one year and in the longer term, a comparison of health related quality of life at 30 days and any surgical adverse events, re-operation and re-admission rates, the relative cost of the two methods of anaesthesia, length of stay and intensive and high dependency bed occupancy.
Overall trial start date
01/06/1999
Overall trial end date
30/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The main criterion for entry into this study is that, in the opinion of the responsible clinician, the patient requiring an endarterectomy is suitable for either local or general anaesthesia, and there is no clear indication for either type. All patients with either symptomatic or asymptomatic internal carotid stenosis for whom surgery is advised are eligible. There is no upper age limit.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5,000 (as of 19/05/08, the total recruited: 3,526)
Participant exclusion criteria
1. Failure to obtain informed consent
2. Patient unable to co-operate with awake testing during local anaesthesia
3. Patient considered unfit for general anaesthesia
4. Patient considered unfit for local anaesthesia
5. Patient requiring simultaneous bilateral carotid endarterectomy
6. Carotid endarterectomy combined with another operative artery bypass surgery
7. Patient has been randomised into the trial previously
Recruitment start date
01/06/1999
Recruitment end date
30/04/2008
Locations
Countries of recruitment
Australia, Austria, Belarus, China, Croatia, Czech Republic, Estonia, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Turkey, Ukraine, United Kingdom
Trial participating centre
Neurosciences Trials Unit
Edinburgh
EH4 2XU
United Kingdom
Sponsor information
Organisation
The Health Foundation (UK)
Sponsor details
90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Health Foundation (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
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18495004
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19041130
Publication citations
-
Protocol
Gough MJ, Bodenham A, Horrocks M, Colam B, Lewis SC, Rothwell PM, Banning AP, Torgerson D, Gough M, Dellagrammaticas D, Leigh-Brown A, Liapis C, Warlow C, GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery., Trials, 2008, 9, 28, doi: 10.1186/1745-6215-9-28.
-
Results
, Lewis SC, Warlow CP, Bodenham AR, Colam B, Rothwell PM, Torgerson D, Dellagrammaticas D, Horrocks M, Liapis C, Banning AP, Gough M, Gough MJ, General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial., Lancet, 2008, 372, 9656, 2132-2142, doi: 10.1016/S0140-6736(08)61699-2.