The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
Condition: Hemostasis, Surgical
Intervention: Epoetin alfa; Standard of Care
Intervention description: 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.; Participants will receive standard of care based on the Institution's treatment policy.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemostasis, Surgical; Epoetin alfa; Surgery; Abdomen; Pelvis; PROCRIT; pRBC; Blood transfusion; Packed red blood cell transfusion

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 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).
    

Eligibility criteria:

        Inclusion Criteria: - Scheduled to undergo elective major abdominal and/or pelvic surgery
        with anticipated significant perioperative ((the time period describing the duration of a
        participants surgical procedure) blood loss (eg, greater than 500 cc and at increased risk
        for blood transfusion) - Hemoglobin greater than 10 g/dL and less than or equal to 13 g/dL
        at screening (Day -13 [13 days prior to surgery] to Day -11) and baseline (Day -10) -
        Patients with reproductive potential and their partners must practice an effective method
        of birth control (eg, prescription oral contraceptives, contraceptive injections,
        intrauterine device, double-barrier method, contraceptive patch, partner sterilization)
        before entry and throughout the study - Female patients with reproductive potential must
        have a negative urine pregnancy test within 7 days of the first dose of PROCRIT - Adequate
        renal (kidney) and adequate hepatic (liver) function assessed within the 21-day screening
        period Exclusion Criteria: - No severe Congestive Heart Failure (New York Heart Association
        Class IV) - No known severe stable or unstable coronary artery disease, or unstable angina
        - No history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months
        before study entry (prior superficial thrombophlebitis is not an exclusion criterion) - No
        history of cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute coronary
        syndrome (unstable Angina, myocardial Infarction), or other arterial thrombosis within 6
        months before study entry - Not anticipated to donate perioperative autologous blood or
        receive transfusions within 21 days prior to baseline or to have greater than 6
        transfusions perioperatively - No prior treatment with PROCRIT or any
        erythropoiesis-stimulating agents (ESAs) within the previous month