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ISRCTN
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ISRCTN89080534
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ClinicalTrials.gov identifier
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Public title
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The use of erythropoietin in cardiac surgery to protect against ischaemia-related injury in kidney and other organ systems
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Scientific title
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Acronym
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EPOCARD
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Serial number at source
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ajmepo1
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Study hypothesis
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To investigate whether pre-treatment with erythropoietin (EPO) reduces the incidence of renal injury associated with surgery under cardiopulmonary bypass.
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Lay summary
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Ethics approval
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Ethics approval details not yet received as of 02/06/06.
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Study design
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Prospective, randomised, double-blind, placebo 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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Ischaemic heart disease
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Participants - inclusion criteria
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1. First-time coronary artery bypass surgery
2. Age >70
3. Serum creatinine >120 µmol/l
4. Diabetes mellitus (diet or medication controlled)
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Participants - exclusion criteria
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1. Hypersensitiviy to mammalian cell-derived products to (human) albumin, to EPO or any of the ingredients of EPO
2. Hypercoagulability
3. Significant psychiatric or neurological disease that would prevent adherence to the requirements of the protocol
4. Immunosuppression immunocompromised (including, but not limited to aquired immune deficiency syndrome (AIDS) and immunosuppressive therapy)
5. Significant hepatic disturbance
6. Chronic renal impairment (requiring haemodialysis or peritoneal dialysis)
7. Pregnant or breast feeding
8. Current treatment with human recombitant erythropoietin
9. Previous cardiac surgery
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/10/2007
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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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84
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Interventions
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Erytropoietin versus placebo in coronary artery bypass graft surgery
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Primary outcome measure(s)
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Change in creatine calculated clearance between preoperative baseline and postoperative day one
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Secondary outcome measure(s)
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1. Oliguria
2. Acute renal failure requiring dialysis
3. Urinary analysis of N-acetyl-BD-glucosaminidase and alpha-1 microglobulin/creatinine ratio
4. Evidence of cardiac injury (troponin I)
5. Neurological injury S-100
6. Evidence of type I neurological outcome (stroke, transient ischaemic attack [TIA])
7. Type II neurological outcome (new deterioration in intellectual function, confusion, agitation, disorientation, memory deficit or seizure)
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Sources of funding
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Roche Products Limited (NEO 029)
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Trial website
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Publications
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Contact name
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Mr
Andrew
Murday
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Address
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Scottish Cardiopulmonary Transplant Unit
Glasgow Royal Infirmary
Alexandra Parade
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City/town
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Glasgow
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Zip/Postcode
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G31 2ER
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Country
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United Kingdom
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Tel
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+44 (0)141 2110553
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Fax
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+44 (0)141 2114845
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Email
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andrew.murday@northglasgow.scot.nhs.uk
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Sponsor
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NHS Greater Glasgow and Clyde (UK)
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Address
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Research and Development Office
4th Floor Walton Building
Glasgow Royal Infirmary
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City/town
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Glasgow
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Zip/Postcode
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G31 2ER
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Country
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United Kingdom
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Tel
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+44 (0)141 2110475
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Email
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fiona.grahams@northglasgow.scot.nhs.uk
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Date applied
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08/05/2006
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Last edited
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07/12/2010
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Date ISRCTN assigned
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02/06/2006
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