NCT00269958

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of two different dosing schedules of epoetin alfa versus placebo for decreasing the need for blood transfusions and preventing the occurrence of severe anemia during the period of time around total hip replacement surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

December 1, 1991

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

December 22, 2005

Last Update Submit

May 16, 2011

Conditions

Anemia

Keywords

hip replacementhip replacement surgerysurgeryanemiatransfusionsblood transfusions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients needing blood transfusions; proportion of patients who develop anemia (defined as hemoglobin <80 grams per liter).

Secondary Outcomes (1)

  • Number of blood units transfused; changes in red cell variables (hemoglobin, hematocrit, and reticulocyte counts); iron stores; nursing needs; scores on well-being tests; number days in hospital after surgery; deep vein clots and other adverse events

Interventions

epoetin alfaDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective, first-time hip-replacement surgery or a second hip-replacement surgery (with surgery taking place within 48 hours of the scheduled time)
  • having a baseline hemoglobin between 110 and 160 grams per liter
  • with no significantly abnormal values for laboratory tests that would indicate an impaired ability to respond to epoetin alfa.

You may not qualify if:

  • Patients with a primary hematologic disease
  • having any clinically significant disease/dysfunction of the neurologic, pulmonary, endocrine, cardiovascular, gastrointestinal, or genitourinary systems
  • who have had a seizure disorder in the past 5 years, or who are currently on anticonvulsant therapy
  • having uncontrolled high blood pressure
  • currently experiencing an ongoing blood loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Janssen-Ortho Inc. Clinical Trial

    Janssen-Ortho Inc., Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 26, 2005

Study Completion

December 1, 1991

Last Updated

May 17, 2011

Record last verified: 2010-04