Procrit Versus Placebo to Determine Efficacy in Pre-Opera... | NCT00624312

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

NCT00624312

Sponsor

University of Louisville

Status

Withdrawn

Last Update Posted

Aug 6, 2021Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Cancer

Interventions

Procrit
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Feb 15, 2008

First Submission Date that Met QC Criteria

Feb 26, 2008

First Posted Date

Feb 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2021

Last Update Posted Date

Aug 6, 2021Actual

Name	Class
Ortho Biotech, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Pre-operatively randomized to Procrit	Drug: Procrit
2	Placebo Comparator	Pre-operatively randomized to placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Procrit	Drug	10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit	1

Measure	Description	Time Frame
Proportion of patients receiving transfusion.		One Year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates