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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: PROCRIT
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PROCRIT<br> | Drug: PROCRIT<br>* 40,000 IU/mL/week for max of 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 40,000 IU/mL/week for max of 12 weeks<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care