Role of Single-dose Intravenous Iron Therapy for the Treatment of Anemia in the Setting of Orthopaedic Trauma: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of participant enrollment and screen failures
研究概览
简要总结
Acute blood loss in orthopaedic trauma and operative fracture care contributes substantially to perioperative anemia, which places participants at increased risk for complications including surgical site infection, cardiovascular complications, and even death. Anemia has further clinical implications in quality of life measures and is associated with fatigue, impaired physical performance, decreased exercise capacity, and mood disturbances. Thus, evaluation and treatment of perioperative anemia is critical in risk mitigation within orthopaedic surgery. The current standard of care for anemia is transfusion of packed red blood cells in only cases of severe anemia due to the substantial associated risks. A safer alternative is desirable because a critical number of participants do not meet the restrictive transfusion threshold and may suffer negative effects from anemia during recovery from the acute insult. The focus of this project is to pilot an investigation of the benefits of intravenous iron therapy (IVIT) in traumatically injured patients. Specifically, Aim I will determine feasibility of study design, recruitment, randomization, intervention implementation, blinded procedures, and retention. In Aim II, time to return to normal hemoglobin following traumatic orthopaedic injury will be assessed. With Aim III, the investigators will measure IVIT effect on participant-reported fatigue, physical function, and depression, and further determine if resolution of anemia is correlated to improvements in these measures in traumatically injured orthopaedic patients. Aim IV will focus on evaluating the role of IVIT on immune cells through a variety of novel laboratory assessments. The investigators expect this study to provide a better understanding of IVIT, which has the potential to alter providers' treatment approach of anemia in participants who sustain traumatic orthopaedic injury, thereby leading to decreased risks and improved recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
Single infusion of low molecular weight Iron Dextran
干预措施: Iron-Dextran Complex Injection [InFed] (Drug)
Placebo
Single infusion of normal saline
干预措施: Saline Placebo (Other)
结局指标
主要结局
Rate of participant enrollment and screen failures
时间窗: 3 months
Appraisal of feasibility based on rate of participant enrollment per year and rate of screening failures.
Patient Reported Outcome Scores: Fatigue
时间窗: 3 months
PROMIS bank v1.0 - fatigue. Computer adaptive test that measures feelings of tiredness likely to decrease one's ability to execute daily activities and function normally in family or social roles. Scored on the T-score metric (average score 50, standard deviation 10). High scores mean more of the concept being measured.
Evaluation of protocol adherence
时间窗: 3 months
Appraisal of feasibility based on proportion of participants completing each follow up visit and proportion of missing data.
次要结局
- Rate of anemia and anemia resolution in participants(3 months)
- Patient Reported Outcome Scores - Depression(3 months)
- Evaluation of ferritin level in response to IVIT after trauma(3 months)
- Evaluation of participant body iron stores in response to IVIT after trauma(3 months)
- Patient Reported Outcome Scores - Physical Function(3 months)
- Patient Reported Outcome Scores - Quality of Life(3 months)
研究者
Zachary Working
Director of Orthopaedic Trauma, Assistant Professor
Oregon Health and Science University
