Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270023
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-12-22
Brief Title:
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic Heart and Blood Vessel or Breast Reduction Surgery Performed in Combination With a Procedure to Reduce Blood Loss During Surgery
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Recombinant Human Erythropoietin R-HuEPO in Non-Anemic Patients Scheduled for Selective Orthopedic and Vascular Surgery or Reductive Mammoplasty to Facilitate Presurgical Autologous Blood Donation Combined With Normo-Volemic Hemodilution NVHD
Status:
COMPLETED
Status Verified Date:
2010-04
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 the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery which is shorter than the conventional 3-week blood donation period before surgery in patients who are not anemic and who will be undergoing orthopedic heart and blood vessel or breast reduction surgery Epoetin alfa is a genetically engineered protein that stimulates red blood cell production Normovolemic hemodilution NVHD withdrawal of a patients blood immediately before surgery immediate replacement of blood with an equal volume of fluid and return of the withdrawn blood after completion of surgery a procedure which reduces the loss of blood during surgery will also be performed
Detailed Description:
Patients undergoing surgery frequently require blood transfusions both during and after the operation Patients often have their own blood collected for this purpose over a standard 3- to 4-week presurgical period However a large percentage of patients are not able to pre-donate their own blood for transfusion Agents that can facilitate self-donation in less time than the conventional 3 weeks before surgery and reduce the need for transfusions from others may improve the overall safety of surgery This is a randomized double-blind placebo-controlled parallel group multicenter study to determine whether epoetin alfa will enable the self-donation of at least 4 units of blood in the shortened presurgical time period of 11 days before surgery which is a shorter period of time than the conventional 3 week blood donation period before surgery in patients who are not anemic and who are undergoing orthopedic heart and blood vessel or breast reduction surgery The study consists of a 7-day screening period during which patients will be tested for eligibility for the study an 11-day treatment blood collection and evaluation period that ends on Day 11 the day of surgery and a post-surgery follow-up period beginning on the evening of Day 11 and ending with a final study visit at the time a patient is discharged from the hospital after surgery Patients will be randomly assigned to one of four treatment groups epoetin alfa 300 unitskilogram Ukg epoetin alfa 600 Ukg placebo to match the volume of epoetin alfa 300 Ukg or placebo to match the volume of epoetin alfa 600 Ukg given by injection into a vein Twice as many patients will receive treatment with epoetin alfa as will receive treatment with placebo A total of 3 doses of study drug will be administered before surgery one dose will be given on each of Days 1 4 and 7 of the study Additionally from Day 1 to the day of hospital discharge all patients will receive 200 milligrams of iron and 5 milligrams of a folate supplement daily by mouth to help the body to increase the production of red blood cells On Day 1 before the first dose of study medication one unit of blood will be collected from each patient and stored for self-donated blood transfusion An additional unit of blood will be obtained from each patient before the administration of study drug and stored for self-donated blood transfusion on each of Days 4 7 and 11 the day of surgery before the operation this will only be performed if the patients hemoglobin is 110 gdL If a patients hemoglobin is lower than 110 gdL no blood will be collected from that patient on these days although study drug will continue to be given Normovolemic hemodilution NVHD will be performed on Day 11 the day of surgery before and during the operation Safety evaluations include laboratory tests vital signs and the recording of adverse events Effectiveness will be assessed by comparing the number of self-donated units of blood obtained within 11 days among the 4 treatment groups and secondarily by comparing the change in hemoglobin immature red blood cells and erythropoietin the red blood cell stimulating hormone levels in the blood among the 4 treatment groups from before the start of study to the end of the study The study hypothesis is that in an abbreviated time period before surgery 11 days epoetin alfa will stimulate the generation of 4 units of self-donated blood in patients who are not anemic who are undergoing orthopedic heart and blood vessel or breast reduction surgery Epoetin alfa 300 unitskilogram Ukg epoetin alfa 600 Ukg or placebo by injection into a vein given on each of Days 1 4 and 7 of the study
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