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

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 2

Conditions

Anemia

Treatments

Drug: Placebo

Drug: PROCRIT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00210626

CR003235

Long Term Treatment Outcomes (;Other Identifier)

PR04-15-001 (Other Identifier)

LTTO (;Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

192 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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