Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa

NCT00210626 | Terminated Phase 2 Results DMC

• 4 other identifiers: CR003235LTTO;Long Term Treatment Outcomes;PR04-15-001
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 21

Brief Summary

The purpose of this trial is to evaluate the physical function outcomes in anemic, critically ill, trauma subjects treated with epoetin alfa (PROCRIT®) compared to placebo.

Conditions

Anemia

Keywords

Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care

Outcome Measures

Primary Outcomes (1)

• SF-36 PF Score

  Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.

  Hospital Discharge to Post-Hospital Discharge Week 24

Secondary Outcomes (1)

• Return to Usual Activity (RTUA)

  Hospital Discharge to Post-Hospital Discharge Week 24

Study Arms (2)

PROCRIT

ACTIVE COMPARATOR

Drug: PROCRIT

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PROCRIT DRUG

40,000 IU/mL/week for max of 12 weeks

PROCRIT

Placebo DRUG

40,000 IU/mL/week for max of 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ICU admission secondary to a blunt multi-system traumatic injury
• A leg or pelvic fracture must be one of the injuries sustained
• Male or female
• Age between 18 and 55 years
• Hemoglobin \<=12g/dL at study entry
• An expected ICU stay \>=2 days
• Glascow Coma Scale (GCS) score must be \>= 13 at hospital admission or within 24 hours of admission
• Documented ability to function independently prior to this hospitalization as determined by a subject or proxy interview using the Karnofsky Performance scale and having a score \>=80
• Subjects (or appropriate legal representative) must sign the informed consent form after the nature of the study has been fully explained
• Female subjects that can become pregnant must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during study
• Subjects must be literate in their native language in order to complete written self-assessments during the post-hospital discharge phase

You may not qualify if:

• Acute burns
• Traumatic Brain Injury (TBI) with admission GCS \<= 12 and/or spinal cord injury
• Cause of injury secondary to a fall from a standing position
• Trauma victims transferred into the participating institution \> 8 hours post injury
• Subjects not expected to survive 12 months given their injuries and/or pre-existing, uncorrectable medical condition
• Chronic renal failure on dialysis
• Significant hematological disease
• All subjects expected to undergo chemotherapy during the course of treatment
• A current diagnosis of uncontrolled hypertension
• New onset seizures (within three months) or seizures not controlled by medication prior to admission
• Gustillo III fracture, open pelvic fracture, traumatic amputation
• Prior history or diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), or genetic coagulation abnormality
• Pregnancy or lactation
• Refusal to accept blood transfusion
• Received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Products, L.P.: collaborator

Study Sites (21)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Santa Barbara, California, United States

Location

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Denver, Colorado, United States

Location

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Gainesville, Florida, United States

Location

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Hollywood, Florida, United States

Location

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Miami, Florida, United States

Location

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Maywood, Illinois, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

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Baltimore, Maryland, United States

Location

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St Louis, Missouri, United States

Location

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Las Vegas, Nevada, United States

Location

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Cincinnati, Ohio, United States

Location

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Dayton, Ohio, United States

Location

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Allentown, Pennsylvania, United States

Location

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Philadelphia, Pennsylvania, United States

Location

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Memphis, Tennessee, United States

Location

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El Paso, Texas, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Morgantown, West Virginia, United States

Location

MeSH Terms

Conditions

Anemia; Critical Illness

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

The study was stopped early due to slow enrollment. Four subjects were randomized but withdrew prior to hospital entry and no data were collected

Results Point of Contact

• Title: Vice President Medical Affairs
• Organization: Centocor Ortho Biotech Services, LLC (COBS)

215-325-4464

Study Officials

• Tracy McGowan

  Janssen Services, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 21, 2014
• Results First Posted: December 22, 2009

Record last verified: 2014-04

Locations

US (21)