Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269971
Status:
WITHDRAWN
Last Update Posted:
2016-09-20
First Post:
2005-12-22
Brief Title:
A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
Official Title:
A Parallel Group Placebo-Controlled Study to Determine an Effective Dose Regimen for EPREX Epoetin Alfa Sterile Solution to Reduce Transfusion Requirements in Patients Undergoing Major Elective Orthopedic Surgery
Status:
WITHDRAWN
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine an effective dose of epoetin alfa to be administered prior to surgery to decrease the need for blood transfusions during hip replacement Epoetin alfa is a genetically engineered protein that stimulates red blood cell production
Detailed Description:
Major surgical procedures may 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 multicenter study in patients scheduled for first time hip replacement surgery The study compares the effectiveness of 2 different doses of epoetin alfa 20000 units or 40000 units per week for reducing the need for blood transfusions during the surgery Eligible patients will be randomly assigned to one of three treatment groups epoetin alfa 20000 units per week epoetin alfa 40000 units per week or placebo Patients will be treated with study medication once a week for 4 weeks before their scheduled surgery Effectiveness will be determined by the number of transfusions required during surgery Other factors that determine effectiveness will be the level of hemoglobin the oxygen-carrying component of red blood cells and the percentage of red blood cells in the patients blood hematocrit prior to surgery the number of developing red blood cells reticulocytes the iron stores in the patients blood prior to surgery the patients quality of life after the surgery and the time that elapses after surgery before the patient is discharged from the hospital Safety evaluations will include the incidence of blood clots in the deep veins the incidence and severity of other 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 before hip replacement surgery will require fewer blood transfusions during the surgery compared with patients treated with placebo and that the lower epoetin alfa dose 20000 units per week is as effective as the higher epoetin alfa dose 40000 units per week Patients will receive 20000 units or 40000 units of epoetin alfa injected under the skin once weekly for 4 weeks or a matching placebo injection containing human serum albumin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None