Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211146
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
A Study to Confirm the Safety and Efficacy of Epoetin Alfa PROCRIT Administered Perioperatively vs the Standard of Care in Blood Conservation in Patients Undergoing Major Elective Spinal Surgery SPINE Study
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-Label Randomized Parallel-Group Study to Confirm the Safety and Efficacy of Epoetin Alfa PROCRIT Administered Perioperatively vs the Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery
Status:
COMPLETED
Status Verified Date:
2010-04
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:
This study is designed to investigate the incidence of deep vein thrombosis in patients receiving a perisurgical regimen of epoetin alfa PROCRITÂ as compared to patients receiving standard of care blood conservation management
Detailed Description:
The objective of the study is to demonstrate that there is no clinically important additional risk for deep vein thrombosis DVT in adult spine surgery using a perisurgical regimen of epoetin alfa PROCRIT versus the standard of care for blood conservation Spine surgery was selected as the population to study because anti-coagulant therapy is not always administered in association with this surgery type In addition the efficacy of epoetin alfa PROCRIT in protecting patients from receiving allogeneic red cell transfusion across adult spinal procedures will be studied Patients scheduled for elective spinal surgery who agree to participate in the study and meet eligibility criteria will be randomly assigned to epoetin alfa PROCRIT or standard of care No perioperative anti-coagulation therapy is to be administered during the study The study hypothesis is that there is no increased risk of DVT in patients receiving perisurgical epoetin alfa PROCRIT treatment Epoetin alfa PROCRIT 600Ukg administered once per week for 3 weeks prior to surgery and on the day of 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