Condition category
Circulatory System
Date applied
08/05/2006
Date assigned
02/06/2006
Last edited
16/12/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Murday

ORCID ID

Contact details

Scottish Cardiopulmonary Transplant Unit
Glasgow Royal Infirmary
Alexandra Parade
Glasgow
G31 2ER
United Kingdom
+44 (0)141 2110553

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ajmepo1

Study information

Scientific title

Acronym

EPOCARD

Study hypothesis

To investigate whether pre-treatment with erythropoietin (EPO) reduces the incidence of renal injury associated with surgery under cardiopulmonary bypass.

Ethics approval

Ethics approval details not yet received as of 02/06/06.

Study design

Prospective, randomised, double-blind, placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Ischaemic heart disease

Intervention

Erytropoietin versus placebo in coronary artery bypass graft surgery

Intervention type

Drug

Phase

Not Specified

Drug names

Erythropoietin

Primary outcome measures

Change in creatine calculated clearance between preoperative baseline and postoperative day one

Secondary outcome measures

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)

Overall trial start date

01/10/2006

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

84

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Scottish Cardiopulmonary Transplant Unit
Glasgow
G31 2ER
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

Research and Development Office
4th Floor Walton Building
Glasgow Royal Infirmary
Glasgow
G31 2ER
United Kingdom
+44 (0)141 2110475
fiona.grahams@northglasgow.scot.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Roche Products Limited (NEO 029)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes