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.

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00270140
First received: December 22, 2005
Last updated: May 17, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Anemia
Blood Transfusions, Autologous
Orthopedic Procedures
Drug: epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Enrollment: 17
Study Start Date: September 1989
Study Completion Date: August 1991
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270140

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.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00270140     History of Changes
Other Study ID Numbers: CR005920
Study First Received: December 22, 2005
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
anemia
blood transfusion
epoetin alfa
erythropoietin
surgery
blood donation
blood

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014