Primary Outcome Measures:
- The primary endpoint is the proportion of patients receiving pRBC (packed red blood cell) transfusions from the day of surgery until hospital discharge in the PROCRIT (Epoetin alfa) group vs. Standard of Care (SOC).
Secondary Outcome Measures:
- The effect of PROCRIT (Epoetin alfa) vs. SOC on hemoglobin, reticulocytes, total number of pRBC transfusions, and length of hospital stay.
This is a randomized, parallel-arm, open-label, multicenter study of up to 64 days duration (Screening Phase of 21 days, Treatment Phase of 15 days, Follow-up Phase of 28 days). Approximately 110 patients undergoing elective major abdominal and/or pelvic surgery with anticipated significant perioperative blood loss (e.g. > 500 mL) and a hemoglobin (Hg) >10 to <=13 g/dL at the baseline will be enrolled. During the Treatment Phase, eligible patients will be randomly assigned (patients 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). Patients in the PROCRIT (Epoetin alfa) group will receive a daily dose of PROCRIT (Epoetin alfa) 300 IU/kg daily for a maximum of 15 doses administered subcutaneously (under the skin). Patients in the SOC group will be treated per the hospital/institution's policy but will not receive PROCRIT (Epoetin alfa) or any other erythropoiesis-stimulating agents (ESAs). Patients will undergo surgery during the Treatment Phase. After surgery, all patients will stay in the study for 4 days (or until hospital discharge) and followed for an additional 28 days (Follow-up Phase). Safety and efficacy evaluations will be performed at specified intervals throughout the study and will consist of assessment of laboratory tests (Complete Blood Count [CBC] [including hemoglobin level], Serum Chemistry), vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events. All patients enrolled in this study (regardless of treatment group) will receive pharmacologic (i.e. anticoagulant) and/or non-pharmacologic prophylaxis (prevention) for deep vein thrombosis (DVT) according to each site's Standard of Care. Patients in the PROCRIT (Epoetin alfa) group will receive iron supplementation while the SOC group will received iron based on the hospital/institution's iron treatment policy.
Patients in the PROCRIT (Epoetin alfa) group will receive 300 IU/kg daily administered under the skin (SC) for a maximum of 15 doses. PROCRIT (Epoetin alfa) will be administered daily for 10 days prior to surgery, on the day of surgery and daily for four days after surgery.