Expired Study
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Louisville, Kentucky 40202


Purpose:

The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.


Criteria:

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


NCT ID:

NCT00624312


Primary Contact:

Principal Investigator
Robert Martin, MD
University of Louisville


Backup Contact:

N/A


Location Contact:

Louisville, Kentucky 40202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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