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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
192
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Orange, California, United States
Unnamed facility
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.
Time frame: Hospital Discharge to Post-Hospital Discharge Week 24
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.
Time frame: Hospital Discharge to Post-Hospital Discharge Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Santa Barbara, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Hollywood, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Maywood, Illinois, United States
Unnamed facility
Springfield, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
...and 11 more locations