The use of erythropoietin in cardiac surgery to protect against ischaemia-related injury in kidney and other organ systems

ISRCTN	ISRCTN89080534
DOI	https://doi.org/10.1186/ISRCTN89080534
Protocol serial number	ajmepo1
Sponsor	NHS Greater Glasgow and Clyde (UK)
Funder	Roche Products Limited (NEO 029)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Andrew Murday
Scientific

Scottish Cardiopulmonary Transplant Unit
Glasgow Royal Infirmary
Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Phone	+44 (0)141 2110553

Primary study design	Interventional
Study design	Prospective, randomised, double-blind, placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EPOCARD
Study objectives	To investigate whether pre-treatment with erythropoietin (EPO) reduces the incidence of renal injury associated with surgery under cardiopulmonary bypass.
Ethics approval(s)	Ethics approval details not yet received as of 02/06/06.
Health condition(s) or problem(s) studied	Ischaemic heart disease
Intervention	Erytropoietin versus placebo in coronary artery bypass graft surgery
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Erythropoietin
Primary outcome measure(s)	Change in creatine calculated clearance between preoperative baseline and postoperative day one
Key secondary outcome measure(s)	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)
Completion date	01/10/2007

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	84
Key inclusion criteria	1. First-time coronary artery bypass surgery 2. Age >70 3. Serum creatinine >120 µmol/l 4. Diabetes mellitus (diet or medication controlled)
Key exclusion criteria	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
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2007

Scottish Cardiopulmonary Transplant Unit

Glasgow
G31 2ER
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan