NCT00269971

Brief Summary

The purpose of this study is to determine an effective dose of epoetin alfa to be administered prior to surgery, to decrease the need for blood transfusions during hip replacement. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 1996

Typical duration for phase_3

Status
withdrawn

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

May 1, 1996

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1999

Completed
6.7 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

September 20, 2016

Status Verified

September 1, 2011

First QC Date

December 22, 2005

Last Update Submit

September 19, 2016

Conditions

AnemiaBlood TransfusionOrthopedic Surgery

Keywords

hip replacementhip replacement surgerysurgeryanemiatransfusionsbloodblood transfusions

Outcome Measures

Primary Outcomes (1)

  • Transfusion requirements at the time of surgery; hemoglobin and hematocrit levels, reticulocyte count, and iron stores prior to surgery; time to hospital discharge after surgery, and the patient's quality of life after surgery.

Secondary Outcomes (1)

  • Deep-vein blood clots; other adverse events, changes in clinical laboratory tests, vital sign measurements, and physical examination findings.

Interventions

epoetin alfaDRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for first-time hip replacement surgery
  • having no major medical conditions
  • having a hemoglobin level of 98 - 137 grams per liter
  • having adequate iron stores
  • not participating in a self-donated blood program

You may not qualify if:

  • Patients with a history of rheumatoid arthritis, blood disorders, recent bleeding episodes or an iron deficiency
  • or having a history of seizures or uncontrolled high blood pressure (diastolic blood pressure \> 100 mmHg)

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
0

Study Design

Study Type
interventional
Phase
phase 3
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 Start

May 1, 1996

Study Completion

April 1, 1999

Last Updated

September 20, 2016

Record last verified: 2011-09