The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
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 and/or pelvic surgery. Standard of Care is defined as the treatment of participants according to the hospital or institution's 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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Multicenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal and/or Pelvic Surgery|
- Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions [ Time Frame: Day of surgery until hospital discharge ] [ Designated as safety issue: No ]
- Hemoglobin Change From Baseline to End of Study [ Time Frame: Baseline (Day-10) to end of study (Day 32) ] [ Designated as safety issue: No ]End of Study Hemoglobin minus baseline Hemoglobin
- Number of pRBC Units Transfused During Study [ Time Frame: Baseline (Day -10) to end of study (Day 32) ] [ Designated as safety issue: No ]
- Hospital Length of Stay [ Time Frame: Surgery to hospital discharge ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Experimental: PROCRIT (epoetin alfa)
Participants will receive PROCRIT (epoetin alfa).
Drug: Epoetin alfa
Participants will receive epoetin alfa 300 IU/kg once daily subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
Other Name: PROCRIT
Experimental: STANDARD THERAPY
Participants will receive standard of care.
Drug: Standard of Care
Participants will receive standard of care based on the Institution's treatment policy.
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 and/or 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 1:1 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350519
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|