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A Study to Determine Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients During the Period of Time Around Major Orthopedic Surgery.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00270088
First Posted: December 26, 2005
Last Update Posted: May 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
The purpose of this study is to evaluate the safety of epoetin alfa and to determine whether epoetin alfa will reduce the need for blood transfusions during the period of time around major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Condition Intervention Phase
Anemia Blood Transfusion Orthopedic Procedures Drug: epoetin alfa Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study to Determine Whether Procrit� (Epoetin Alfa) Can Reduce Peri-Operative Transfusion Requirements in Subjects Undergoing Major Orthopedic Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients in each treatment group, overall, and within each baseline hemoglobin group requiring blood transfusion following major orthopedic surgery

Secondary Outcome Measures:
  • Changes in hemoglobin, hematocrit, and red blood cell count; Assessment of safety (laboratory tests, vital signs, and physical examination from start to end of study); Assessment of adverse events

Enrollment: 316
Study Start Date: April 1993
Study Completion Date: August 1994
Detailed Description:
Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. These transfusions can result in adverse reactions, such as a blood clot in a deep vein. Agents that can reduce the need for transfusions would improve the overall safety of the surgery. In previous studies with epoetin alfa, patients have generally experienced an increase in the percentage of red blood cells in whole blood, a decrease in blood transfusions, and a decrease in the number of surgery-related adverse reactions, with good tolerance of the drug. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study will evaluate the safety of epoetin alfa and to determine whether epoetin alfa will reduce the need for blood transfusions in patients who are expected to require at least 2 units of blood during the period of time around major orthopedic hip or knee surgery. Before the start of the study, patients are screened for eligibility and a test is performed to determine the amount of hemoglobin present in each patient's blood. Based on these results, patients are then divided into 3 groups: patients with hemoglobin <=10 grams/deciliter (g/dL), patients with hemoglobin >10 and <=13 g/dL, and patients with hemoglobin >10 g/dL. Within each of these groups, patients will be randomly assigned to receive 1 of 3 treatments: epoetin alfa 300 units/kilogram (U/kg), epoetin alfa 100 U/kg, or placebo, by injection beneath the skin, beginning 10 days before scheduled surgery and ending 4 days after surgery. Additionally, from 10 days before surgery until 4 days after surgery all patients will receive a 150 milligram iron supplement daily by mouth, and from the day of surgery (following surgery) until 6 days after surgery, all patients will be given Coumadin 5 milligrams daily (a drug to prevent a blood clot in a deep vein). Safety evaluations include laboratory tests, physical examination, vital signs, and the recording of adverse events performed throughout the study until the patient is discharged from the hospital. In addition, six weeks after surgery, laboratory tests are performed, vital signs are measured, and any adverse events are recorded. Ultrasound is performed before the start of the study and on Day 5 after surgery to determine if there is a blood clot in a deep vein. Effectiveness will be determined by reduction in the need for transfusions during the period of time around the surgery. The study hypothesis is that patients treated with epoetin alfa will require fewer transfusions during the period of time around surgery than patients treated with placebo. Epoetin alfa 300 units/kilogram (U/kg), epoetin alfa 100 U/kg, or placebo, by injection beneath the skin beginning 10 days before scheduled surgery and ending 4 days after surgery.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for major orthopedic surgery involving the hip or knee, who are expected to require transfusion of at least 2 units of red blood cells
  • who are unwilling or unable to participate in a transfusion program wherein a patient's own blood is donated before surgery
  • in good general health
  • having no significantly abnormal laboratory blood, urine, or stool tests

Exclusion Criteria:

  • Patients having any blood disease, hepatitis B, signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment, or who have tested positive for HIV (human immunodeficiency virus)
  • who are unable to use Coumadin (a medication to prevent blood clots in veins)
  • having a recent history of stomach or intestinal bleeding, bleeding inside the skull, or the signs and symptoms of significant and ongoing blood loss
  • having a seizure disorder, uncontrolled high blood pressure, the presence of active inflammatory disease (i.e., rheumatoid arthritis, however, patients with osteoarthritis may be included in this study) or the signs and symptoms of a significant disease and/or dysfunction
  • received a blood transfusion within 1 month before the start of the study, received medication known to suppress formation of red blood cells within 1 month before the start of the study, or having infections or cancers that may make it difficult to respond to the study drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270088


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:
ClinicalTrials.gov Identifier: NCT00270088     History of Changes
Other Study ID Numbers: CR005899
First Submitted: December 22, 2005
First Posted: December 26, 2005
Last Update Posted: May 18, 2011
Last Verified: February 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
blood transfusion
epoetin alfa
epogen
erythropoietin
orthopedic procedures
orthopedic surgery

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics