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

NCT00336466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2007-11-27

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery
  • Brain Injury

Interventions

DRUG

Human recombinant erythropoietin

Sponsors & Collaborators

  • Calgary Health Region

    collaborator OTHER

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • David Zygun, MD · University of Calgary and Calgary Health Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2005-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00336466 on ClinicalTrials.gov