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ISRCTN
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ISRCTN82938832
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ClinicalTrials.gov identifier
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Public title
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Remote ischaemic preconditioning to reduce myocardial complications following head and neck cancer surgery
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Scientific title
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A prospective double-blind randomised controlled trial of the impact of remote-organ ischaemic preconditioning on perioperative myocardial morbidity and postoperative complications in head and neck surgery: Myocardial Event Reduction with Ischaemic-preconditioning Therapy (MERIT)
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Acronym
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MERIT
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Serial number at source
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10/H0801/2
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Study hypothesis
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Does remote ischaemic preconditioning reduce the incidence of myocardial damage associated with major head and neck surgery? As a secondary hypothesis, does remote ischaemic preconditioning reduce the degree of post-operative inflammation, the number and severity of post-operative complications, length of critical care stay, and the overall duration of hospitalisation?
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Lay summary
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Ethics approval
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Royal Marsden Research Ethics Committee approved on the 2nd February 2010 (ref: 10/H0801/2)
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Study design
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Double-blind randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Squamous cell carcinoma of the upper aerodigestive tract
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Participants - inclusion criteria
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1. Patients aged under 90 years, either sex
2. Squamous cell carcinoma of the upper aerodigestive tract (head and neck cancer)
3. Undergoing excision of the primary site tumour and removal of cervical lymph nodes as part of the management of their condition
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Participants - exclusion criteria
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1. Patients over 90 years of age
2. Patients unable to give informed consent
3. Patients unfit to undergo general anaesthesia
4. Patients undergoing only neck dissection surgery
5. Patients with non-squamous cell carcinoma pathology
6. Patients undergoing excision of tumours of the skull base
7. Diabetic patients taking sulphonylurea medications
8. Patients taking nicorandil
9. Patients undergoing trans-oral laser resection of tumours
10. Patients with a previous history of deep-vein thrombosis or pulmonary embolism
11. Patients with known peripheral vascular disease who have an Ankle-Brachial Pressure Index less than 0.7)
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Anticipated start date
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05/08/2010
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Anticipated end date
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05/08/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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92
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Interventions
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The intervention group will receive remote ischaemic preconditioning which will be achieved immediately after induction of anaesthesia using an orthopaedic lower limb tourniquet inflated to 50 mmHg above the systolic pressure for two cycles of five minutes, interleaved with a single seven-minute period of reperfusion.
The control group will not have remote ischaemic preconditioning; they will have a lower limb torniquet placed around their leg but this will not be inflated.
The duration of treatment is 20 minutes and the follow-up is six months.
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Primary outcome measure(s)
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Incidence of myocardial injury following head and neck surgery, as measured by the level of cardiac troponin enzyme at days 1, 3 and 7 after the operation.
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Secondary outcome measure(s)
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1. The rate of rise of C-reactive protein levels in the post-operative period (the inflammatory gradient)
2. Incidence and severity of post-operative complications as graded on a validated complications grading system
3. Length of stay in the Intensive Care, High-dependency and ward
4. Patient weight and swallowing status during follow-up
5. One-year MACE (Major Acute Cardiovascular Event) rate
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Sources of funding
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Imperial College Healthcare NHS Trust (UK)
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Trial website
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http://www.scientificsurgery.co.uk/merit-trial
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Publications
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Contact name
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Dr
Patrick
Doyle
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Address
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Department of Anaesthesia
Imperial College Healthcare NHS Trust
Charing Cross Hospital
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Email
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patrick.doyle@imperial.nhs.uk
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Sponsor
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Imperial College Healthcare NHS Trust (UK)
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Address
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c/o Michelle Quaye
The Joint Research Office
Hammersmith Hospital
Du Cane Road
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City/town
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London
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Zip/Postcode
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W14 0HS
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Country
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United Kingdom
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Sponsor website:
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http://www.imperial.nhs.uk/
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Date applied
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07/07/2010
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Last edited
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29/07/2010
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Date ISRCTN assigned
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29/07/2010
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