NCT00336466

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

June 12, 2006

Last Update Submit

November 26, 2007

Conditions

Cardiac SurgeryBrain Injury

Keywords

Cardiac bypass surgery

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Feasibility

Secondary Outcomes (1)

  • Incidence of Neurocognitive Dysfunction

Interventions

Human recombinant erythropoietinDRUG

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First time cardiac surgical patients
  • Elective or urgent on pump coronary artery bypass grafting (CABG)
  • Age 45-75
  • Signed, informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • David Zygun, MD

    University of Calgary and Calgary Health Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 13, 2006

Study Start

September 1, 2004

Study Completion

May 1, 2005

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

CA(1)