A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Facilitating the Presurgical Collection of Blood to be Used for Self-donation During Surgery on the Spine, Hip, or Knee.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00270140

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa at doses of 150, 300, or 600 units per kilogram of body weight versus placebo in facilitating presurgical collection of blood for self-donation during surgery of the knee, hip or spine. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Condition or Disease	Intervention/Treatment	Phase
Anemia Blood Transfusions, Autologous Orthopedic Procedures	Drug: epoetin alfa	Phase 3

Detailed Description

Major surgical procedures may require transfusion of several units of blood. Blood transfusions from other people may be associated with transfusion reactions that cause fever or with viral infections that can be carried (and donated) in blood. However, self-donations of blood may cause anemia in a patient who will be undergoing surgery a few weeks later. Previous research with epoetin alfa suggests that epoetin alfa speeds up the rate of red blood cell production and has a beneficial effect on anemia. This randomized, double-blind, placebo-controlled, multicenter study is designed to determine whether treating patients with epoetin alfa will stimulate a person's bone marrow to produce red blood cells and therefore increase a patient's ability to self-donate blood prior to major surgery for joint diseases. Patients will be randomly assigned to receive 150, 300, or 600 units of epoetin alfa per kilogram of body weight, or matching placebo, injected into a vein on the first study day, and every 3 to 4 days thereafter for 21 days. Effectiveness will be determined by the number of units of blood that can be donated by patients during the study, the number of units of non-self-donated blood used during surgery, the total red cell volume of the self-donated blood, the total red cell production, and the percentage of sub-standard units of blood that are self-donated. Safety evaluations including the incidence of adverse events, physical examinations, and clinical laboratory tests will be performed throughout the study. The study hypothesis is that patients treated with epoetin alfa will be able to donate more units of blood than those patients who receive placebo. Epoetin alfa, 150, 300, or 600 units per kilogram of body weight, or placebo, injected into a vein every three to four days for 21 days (6 doses) during the period before surgery.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of Multiple Doses of R-HuEPO in Facilitating Presurgical Autologous Blood Donation

Study Start Date :

Sep 1, 1989

Actual Study Completion Date :

Aug 1, 1991

Outcome Measures

Primary Outcome Measures

Number of units of units of blood donated by the patient; Number of units of donor blood transfused during surgery; Total red cell volume and percentage in self-donated blood; Percentage of sub-standard units of blood self-donated []

Secondary Outcome Measures

Percentage in each treatment group of patients requiring blood donated by others; Safety evaluations including the incidence of adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients scheduled for surgery on the knee, hip, or spine between 25 and 35 days after starting epoetin alfa therapy
having a hematocrit (percentage of red cells in the blood) of >39 percent and <=50 percent
in good general health

Exclusion Criteria:

Patients having a history of any primary blood disease
having a history of artery blockage in the heart, body or brain, or a history of seizures
having uncontrolled high blood pressure, a folate deficiency, vitamin B12 deficiency or iron deficiency anemia, active inflammatory disease (except osteoarthritis or rheumatoid arthritis) or a disease that destroys blood cells
losing blood from the stomach, intestines or elsewhere in the body
having received therapy with any drug known to affect red blood cell formation (such as chemotherapy for cancer)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.