Cardiac Surgery Clinical Trial
Official title:
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS): A Randomized, Double-Blind, Placebo Controlled Proof-of-Concept Clinical Trial.
Verified date | November 2007 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Hospital | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Calgary Health Region, Ortho Biotech, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | |||
Primary | Feasibility | |||
Secondary | Incidence of Neurocognitive Dysfunction |
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