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Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations

Information source: University of Louisville
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: Procrit (Drug); Placebo (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: University of Louisville

Official(s) and/or principal investigator(s):
Robert Martin, MD, Principal Investigator, Affiliation: University of Louisville

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.

Clinical Details

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

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

Primary outcome: Proportion of patients receiving transfusion.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Louisville, Louisville, Kentucky 40202, United States
Additional Information

Starting date: February 2008
Last updated: September 30, 2013

Page last updated: August 23, 2015

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