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

NCT ID: NCT00210626

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-06-30

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.

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PROCRIT

Group Type: ACTIVE_COMPARATOR

PROCRIT

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

PROCRIT

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Products, L.P.

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracy McGowan

Role: STUDY_DIRECTOR

Janssen Services, LLC

Locations

Birmingham, Alabama, United States

Orange, California, United States

Santa Barbara, California, United States

Denver, Colorado, United States

Gainesville, Florida, United States

Hollywood, Florida, United States

Miami, Florida, United States

Maywood, Illinois, United States

Springfield, Illinois, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Allentown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

El Paso, Texas, United States

Norfolk, Virginia, United States

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

LTTO;

Identifier Type: OTHER

Identifier Source: secondary_id

Long Term Treatment Outcomes;

Identifier Type: OTHER

Identifier Source: secondary_id

PR04-15-001

Identifier Type: OTHER

Identifier Source: secondary_id

CR003235

Identifier Type: -

Identifier Source: org_study_id