Clinical trial NCT00210626: Assess Functional Outcomes in Anemic, Critically Ill, Trauma Patients When Taking Epoetin Alfa
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anemia
Keywords: Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Ortho Biotech Products, L.P.
First posted: 2005-09-21
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SF-36 PF Score
timeFrame: Hospital Discharge to Post-Hospital Discharge Week 24
Secondary outcomes:
measure: Return to Usual Activity (RTUA)
timeFrame: Hospital Discharge to Post-Hospital Discharge Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Orange
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Maywood
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: El Paso
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Janssen Services, LLC
name: Tracy McGowan
role: STUDY_DIRECTOR
References: