A Study to Evaluate the Effectiveness and Safety of Epoetin Alfa During the Period When One is Donating One's Own Blood Before Surgery.

NCT00270179 | Completed Phase 3

• 1 other identifier: CR005926
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow to produce red blood cells and therefore increases a patient's ability to self-donate blood prior to major surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Conditions

Anemia

Keywords

Anemia; blood transfusion; epoetin alfa; erythropoietin; surgery; self-blood donation

Outcome Measures

Primary Outcomes (1)

• Units of blood that can be obtained per patient; Change from pre-study to post-study in hemoglobin and hematocrit; Transfusions required around the time of surgery

Secondary Outcomes (1)

• Safety (clinical laboratory tests, vital signs, incidence and severity of any adverse or unusual experiences associated with drug administration)

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for major orthopedic surgery
• expected to have surgery between 25 and 35 days after starting epoetin alfa and expected to require transfusion of at least 3 units of red blood
• in good general health, with no clinically significantly abnormalities in blood and urine test values, blood clotting, or tests that check for blood in the feces
• who are not severely obese

You may not qualify if:

• Patients with a history of blood disease other than mild anemia or currently having a percentage of red blood cells \>50% of the blood
• having the presence or history of significant diseases, especially those known to be carried in the blood, to affect the blood, or that require chemotherapy or other drugs that suppress resistance to disease or red blood cells
• having a history of seizure or uncontrolled hypertension
• having clinically significant bleeding in the stomach/intestines or elsewhere
• received a blood transfusion or received androgen therapy within 1 month prior to the start of study

Sponsors & Collaborators

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

Related Links

• A study to evaluate the effectiveness and safety of epoetin alfa during the period when one is donating one's own blood before surgery.

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 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 Completion: May 1, 1988
• Last Updated: May 18, 2011

Record last verified: 2010-04