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A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Proportion of patients receiving transfusion.

Outcome Time Frame:

One Year

Safety Issue:

No

Principal Investigator

Robert Martin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville

Authority:

United States: Food and Drug Administration

Study ID:

07.0048

NCT ID:

NCT00624312

Start Date:

February 2008

Completion Date:

January 2010

Related Keywords:

  • Cancer
  • Procrit
  • Erythropoietin
  • Patients undergoing major surgical oncology operations

Name

Location

University of Louisville Louisville, Kentucky  40202