A Study of the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Patients Who Are Undergoing Orthopedic Surgery and Who Have Low Hematocrit Levels (the Percent of Red Blood Cells in Whole Blood)

NCT00270114 | Completed Phase 2

• 1 other identifier: CR005914
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa and to determine whether epoetin alfa will facilitate self-donation of blood before surgery in patients who have anemia, (as indicated by low hematocrit levels, the percent of red blood cells in whole blood) and who will be undergoing orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Conditions

Anemia; Blood Transfusion; Orthopedic Procedures

Keywords

Anemia; blood transfusion, autologous; epoetin alfa; epogen; erythropoietin; orthopedic procedures; orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Number of self-donated units of blood and the total volume of red blood cells donated; Number of blood units from other donors used for transfusion during surgery

Secondary Outcomes (1)

• Changes in hemoglobin, hematocrit, red blood cell count, and effects of oral iron versus oral plus intravenous iron from before the study to the end of study; Assessment laboratory tests, vital signs, physical examination, and adverse events

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for hip replacement surgery
• having an anticipated requirement of 3 or more units of blood
• having a hematocrit level \<=0.39
• having a hemoglobin level \<= 12.5 grams/deciliter
• having laboratory tests within normal ranges, including stool negative for occult blood

You may not qualify if:

• Patients with a history of any blood disease
• having signs and symptoms of significant disease/dysfunction, or signs and symptoms of significant ongoing blood loss
• having uncontrolled high blood pressure, or a folate, vitamin B12, or iron deficiency, or signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment
• taking medication known to suppress the formation of red blood cells within 1 month before the start of the study
• having a history of seizures, or the presence of active inflammatory disease (e.g., rheumatoid arthritis), however, patients with osteoarthritis may be included in this study

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A study of the safety and effectiveness of epoetin alfa in facilitating self-donation of blood before surgery in patients who are undergoing orthopedic surgery and who have low hematocrit levels (the percent of red blood cells in whole blood)

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Completion: March 1, 1991
• Last Updated: May 18, 2011

Record last verified: 2010-04