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ISRCTN
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ISRCTN00525237
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ClinicalTrials.gov identifier
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Public title
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An international multicentre randomised trial comparing general anaesthetic versus local anaesthetic for carotid surgery
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Scientific title
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Acronym
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GALA
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Serial number at source
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2268/1979
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Ethics approval received from the Northern and Yorkshire MREC on the 28th August 1998 (pilot phase) and 22nd April 2003 (main phase).
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Study design
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Randomised controlled trial
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Countries of recruitment
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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
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Disease/condition/study domain
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Carotid stenosis (at risk from stroke)
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/06/1999
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Anticipated end date
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30/04/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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5,000 (as of 19/05/08, the total recruited: 3,526)
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Interventions
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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.
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Primary outcome measure(s)
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The proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction (MI) 30 days post-surgery.
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Secondary outcome measure(s)
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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.
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Sources of funding
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The Health Foundation (UK)
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Trial website
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http://www.galatrial.com
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18495004
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19041130
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Contact name
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Ms
Bridget
Colam
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Address
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Neurosciences Trials Unit
Bramwell Dott Building
Western General Hospital
Crewe Road
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City/town
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Edinburgh
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Zip/Postcode
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EH4 2XU
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Country
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United Kingdom
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Tel
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+44 (0)131 537 2930
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Fax
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+44 (0)131 332 5150
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Email
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gala@skull.dcn.ed.ac.uk
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Sponsor
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The Health Foundation (UK)
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Address
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90 Long Acre
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City/town
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London
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Zip/Postcode
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WC2E 9RA
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Country
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United Kingdom
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Tel
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+44 (0)20 7257 8000
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Fax
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+44 (0)20 7257 8001
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Email
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info@health.org.uk
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Sponsor website:
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http://www.pppfoundation.org.uk/
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Date applied
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12/09/2002
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Last edited
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31/12/2008
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Date ISRCTN assigned
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12/09/2002
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