The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Context: Neurocognitive dysfunction complicates coronary artery bypass graft surgery. Neurocognitive dysfunction is a measurable problem with thinking. Erythropoietin may be a neuroprotectant.

Objective: To investigate the feasibility and safety of three doses of human recombinant erythropoietin to reduce neurocognitive dysfunction in coronary artery bypass graft patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborators: Calgary Health Region; Ortho Biotech, Inc.
• Treatments: Epoetin Alfa; Neuroprotective Agents

Criteria

Inclusion Criteria:

• First time cardiac surgical patients

• Elective or urgent on pump coronary artery bypass grafting (CABG)

• Age 45-75

• Signed, informed consent

Exclusion Criteria:

• Emergent CABG less than 48 hours from presentation

• Symptomatic cerebrovascular disease

• Atrial fibrillation

• Congestive Heart Failure within 2 weeks of surgery

• Malignancy or pre-malignant state within 5 years

• Significant Kidney disease (creatinine >150 umol/L)

• Significant Liver disease (Bilirubin > 20 umol/L)

• Significant Lung Disease (FEV1< 1.5 L, pO2 <70 on room air, pCO2 >45)

• Psychiatric Illness requiring medication

• Alcohol Abuse

• Less than Grade 7 education or inability to read

• Allergy to Eprex, past history of pure red cell aplasia

• Anemia or untreated iron deficiency

• Pregnancy