Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350519
Status:
TERMINATED
Last Update Posted:
2013-07-22
First Post:
2006-07-07
Brief Title:
The Safety and Effectiveness of PROCRIT Epoetin Alfa in Patients Undergoing Elective Major Abdominal andor Pelvic Surgery
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open Label Multicenter Randomized Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal andor Pelvic Surgery
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to compare the effect of perioperative the time period describing the duration of a participants surgical procedure administration of PROCRIT to that of Standard of Care SOC on the proportion of participants receiving pRBC packed red blood cells transfusions from the day of surgery to the day of hospital discharge in participants undergoing elective major abdominal andor pelvic surgery Standard of Care is defined as the treatment of participants according to the hospital or institutions policy but where participants will not receive PROCRIT Epoetin alfa or any other erythropoiesis-stimulating agents ESAs agents that stimulate the production of red blood cells in the bone marrow
Detailed Description:
This is a randomized the study medication is assigned by chance parallel-arm each group of participants will be treated at the same time open-label all people know the identity of the intervention multicenter study The study consists of screening phase of 21 days treatment phase of 15 days follow-up phase of 28 days Approximately 110 participants undergoing elective major abdominal andor pelvic surgery will be enrolled During the Treatment Phase eligible participants will be randomly assigned participants are assigned to a treatment group based on chance in a 11 ratio to either PROCRIT Epoetin alfa or the Standard of Care SOC group that will not receive any erythropoiesis-stimulating agents ESAs Participants will undergo surgery during the Treatment Phase After surgery all participants will stay in the study for 4 days or until hospital discharge and followed for an additional 28 days Follow-up Phase Safety evaluations will include assessment of adverse events clinical laboratory tests electrocardiogram vital signs and physical examination which will be monitored throughout the study The duration of the study for each participant will be approximately 64 days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPOSUR4005 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |