Clinical trial NCT00624312: Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cancer
Keywords: Procrit
Erythropoietin
Patients undergoing major surgical oncology operations
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Ortho Biotech, Inc.
First posted: 2008-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Proportion of patients receiving transfusion.
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: