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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 192
- 主要终点
- SF-36 PF Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PROCRIT
干预措施: PROCRIT (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
SF-36 PF Score
时间窗: Hospital Discharge to Post-Hospital Discharge Week 24
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.
次要结局
- Return to Usual Activity (RTUA)(Hospital Discharge to Post-Hospital Discharge Week 24)