Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270062
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-12-22
Brief Title:
A Study to Evaluate the Safety of Epoetin Alfa and Its Effectiveness in Facilitating the Presurgical Collection of Blood From Anemic Patients for Possible Self-transfusion During and After Scheduled Joint Surgery
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study to Determine Whether R-HuEPO Can Facilitate Presurgical Autologous Blood Donation in Patients With Low Hematocrit Levels
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of epoetin alfa and its effectiveness in facilitating the presurgical collection of blood from anemic patients for possible self-transfusion during and after scheduled joint surgery and its effectiveness in reducing surgery-related transfusion requirements Epoetin alfa is a genetically engineered protein that stimulates red blood cell production
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 infections such as hepatitis or AIDS that are 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 increases the rate of red blood cell production and decreases anemia This randomized double-blind placebo-controlled multicenter study is designed to determine whether epoetin alfa in patients with low hematocrit red blood cell percentage 39 percent will stimulate the bone marrow to produce red blood cells and therefore increase a patients ability to self-donate blood prior to major surgery for joint diseases Patients will be randomly assigned to receive either 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 self-donated blood collected the number of units of donor blood used at the time of surgery and the red blood cell percentages just before surgery 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 during the 3 weeks prior to surgery will need fewer donor-donated units of blood and will have a higher level of red blood cells than patients who receive placebo 600 units of epoetin alfa per kilogram of body weight or an equivalent volume of placebo injected into a vein every 3 to 4 days for 21 days 6 doses during the period before surgery
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