Status:
COMPLETED
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Calgary Health Region
Ortho Biotech, Inc.
Conditions:
Cardiac Surgery
Brain Injury
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
Context: Neurocognitive dysfunction complicates coronary artery bypass graft surgery. Neurocognitive dysfunction is a measurable problem with thinking. Erythropoietin may be a neuroprotectant. Object...
Detailed Description
Coronary artery bypass surgery (CABG) is performed each year on over 500,000 patients in the US and almost 30,000 patients in Canada to treat coronary artery disease. However, it is complicated by a s...
Eligibility Criteria
Inclusion
- First time cardiac surgical patients
- Elective or urgent on pump coronary artery bypass grafting (CABG)
- Age 45-75
- Signed, informed consent
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00336466
Start Date
September 1 2004
End Date
May 1 2005
Last Update
November 27 2007
Active Locations (1)
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1
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9