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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Recombinant Human Erythropoietin (Epoetin Alfa (PROCRIT®)) on Functional Outcomes in Anemic, Critically Ill, Trauma Subjects

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.

Study Overview

• Status: Terminated
• Conditions: Anemia
• Intervention / Treatment: Drug: PROCRIT; Drug: Placebo

Detailed Description

The overall study design is based on the assumption that the maximum increase in red blood cells and their effect often does not occur while a subject is in the ICU and acutely ill. The study hypothesis is that a higher hemoglobin (red blood cells) carries more oxygen and delivers oxygen to the tissues. This should increase the ability of the injured subject to tolerate the physical exertion involved in the recuperative process and thus recover earlier than someone with a lower hemoglobin.

One milliliter of a colorless liquid is injected under the subjects skin weekly during their hospital stay and weekly for up to an additional 12 weeks after hospital discharge.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • California
    • Orange, California, United States
    • Santa Barbara, California, United States
  • Colorado
    • Denver, Colorado, United States
  • Florida
    • Gainesville, Florida, United States
    • Hollywood, Florida, United States
    • Miami, Florida, United States
  • Illinois
    • Maywood, Illinois, United States
    • Springfield, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Dayton, Ohio, United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
  • Tennessee
    • Memphis, Tennessee, United States
  • Texas
    • El Paso, Texas, United States
  • Virginia
    • Norfolk, Virginia, United States
  • West Virginia
    • Morgantown, West Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Treatment with any recombinant human erythropoietin within 30 days prior to enrollment - Known hypersensitivity to human albumin or mammalian cell-derived products or epoetin alfa
• Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 40,000 IU/mL/week for max of 12 weeks
Active Comparator: PROCRIT	Drug: PROCRIT; 40,000 IU/mL/week for max of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to Usual Activity (RTUA)	Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.	Hospital Discharge to Post-Hospital Discharge Week 24

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: Ortho Biotech Products, L.P.
• Investigators: Study Director: Tracy McGowan, Janssen Services, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Hematologic Diseases; Critical Illness; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: CR003235; LTTO; (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.); Long Term Treatment Outcomes; (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.); PR04-15-001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)