Cancer
Conditions
Keywords
Procrit, Erythropoietin, Patients undergoing major surgical oncology operations
Brief summary
The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.
Interventions
DRUGProcrit
10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit
DRUGPlacebo
10 days prior to surgery - injection with 60,000 IU of placebo Day of surgery - injection with 60,000 IU of placebo
Sponsors
Ortho Biotech, Inc.
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients receiving transfusion. | One Year |
Countries
United States
Outcome results
None listed