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A Study to Determine the Safety of Epoetin Alfa and Whether Epoetin Alfa Can Reduce the Need for Blood Transfusions in Patients After Major Orthopedic Surgery.

2014-08-27 03:46:59 | BioPortfolio

Summary

The purpose of this study is to determine the safety of epoetin alfa and to determine the effectiveness of epoetin alfa in reducing the need for blood transfusions after major orthopedic surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Description

Patients undergoing major orthopedic surgery frequently require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the need for blood transfusions. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin, that stimulates red blood cell production. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study compares the effectiveness of epoetin alfa in reducing the need for blood transfusions in patients who are expected to require at least 2 units of blood following major orthopedic surgery. Eligible patients will be randomly assigned to receive either epoetin alfa (100 or 300 U/kg, depending upon their body weight) or a matching placebo, by injection beneath the skin starting 10 days before scheduled surgery, on the day of surgery (after surgery), and for 4 days after surgery. Additionally, all patients will start taking an oral iron supplement at least 10 days before their scheduled surgery. Effectiveness will be determined by the number of transfusions required following surgery, and on changes in hematocrit (iron-containing pigment in red blood cells), hemoglobin (oxygen-carrying component of red blood cells), and reticulocyte (immature red blood cells) levels from the start of the study to the end of the study. Safety evaluations will include the incidence and severity of adverse events, and changes in clinical laboratory tests, vital signs, and physical examination findings throughout the study. The study hypothesis is that patients treated with epoetin alfa will require fewer blood transfusions after surgery than patients treated with placebo.

Epoetin alfa (300 U/kg or 100 U/kg), or matching placebo, by injection beneath the skin beginning 10 days before scheduled surgery and ending 4 days after surgery.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Anemia

Intervention

epoetin alfa

Status

Completed

Source

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

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:46:59-0400

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This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).

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Orthopedics
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...


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