A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations
Inclusion Criteria:
- Undergoing a major surgical oncology procedure as defined below:
- Pancreatectomy
- Hepatectomy
- Esophagectomy
- Gastrectomy
- Retroperitoneal Sarcoma Resection
- 18 years of age and older
- Hemoglobin level of ≥ 10g/dL to < 13g/dL, within 10 days of enrollment
- If female of child-bearing potential, negative pregnancy test within 14 days prior to
surgery
- If subject is a sexually active male or a sexually active female of child- bearing
potential, subject agrees to use a medically accepted form of contraception from the
time of enrollment to completion of all follow-up study visits
- IRB-approved informed consent, signed by the subject or the subject's legally
authorized representative ≥ 18 years of age
Exclusion Criteria:
- Pre-operative hemoglobin level ≥ 13g/dL or < 10g/dL
- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic
pressure ≥ 110)
- History of allergy to Procrit®
- Known hypersensitivity to mammalian cell-derived products or human albumin
- History of spontaneous venous thrombotic vascular events
- Anemia due to factors other than cancer,(e.g. iron deficiency, B12 deficiency)
- History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE),
or other venous thrombotic events. Prior superficial thrombophlebitis is not an
exclusion criterion
- History of (within 6 months) uncontrolled cardiac arrhythmias, cerebrovascular
accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or
other arterial thrombosis. ACS includes Unstable Angina, Q wave Myocardial Infarction
(QwMI), and non-Q wave myocardial infarction (NQMI)
- Currently receiving therapeutic or prophylactic anticoagulants for conditions other
than planned surgery. The only exceptions are low dose aspirin (≤ 325 mg/day) or low
dose anticoagulant to maintain patency of intravenous (IV) lines
- Patient is a candidate for autologous blood transfusion