The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemoglobin Concentrations
研究概览
简要总结
The purpose of this study is to test a multi-faceted anemia treatment plan to reduce the severity of anemia and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).
详细描述
Anemia is common during critical illness and is associated with impaired outcomes during and after hospitalization. The goal of this investigation is to test a multi-faceted anemia prevention and targeted treatment bundle to attenuate anemia development and promote functional recovery in the setting of critical illness. Specifically, this will be a pragmatic phase II clinical trial of a multi-faceted anemia prevention and treatment bundle with 3 aspects (optimized phlebotomy practice, clinical decision support, targeted pharmacologic anemia treatment) assessing the impact of the intervention on hemoglobin concentrations (primary aim), transfusion utilization, and functional outcomes through 3 months after hospitalization.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form (may be completed by legal proxies for those patients unable to provide consent, i.e. sedation/intubation)
- •Stated willingness to comply with all study procedures and availability for the duration of the study, including follow-up assessments
- •Current ICU admission at Mayo Clinic Rochester with anticipated ICU duration >48 hours after enrollment
- •Current ICU duration < 7 days
- •Patients embedded in the local or regional Mayo Clinic Health System to facilitate post-hospitalization outcome assessment
- •Moderate-to-severe anemia (i.e. hemoglobin concentration < 10 g/dL) at the time of enrollment, with the hemoglobin concentration assessed no more than 24 hours prior to enrollment. If RBC transfusion has been administered between the qualifying hemoglobin assessment and enrollment, a repeat hemoglobin will be required prior to enrollment to ensure that it remains < 10 g/dL.
排除标准
- •Recent or current IV iron or erythropoiesis stimulating agent (ESA) use (i.e. darbepoetin, Aranesp, erythropoietin, Epogen, Procrit, Retacrit) within 30 days of enrollment
- •Severe anemia prior to hospitalization (i.e. hemoglobin <9 g/dL within 90 days of admission)
- •Known allergic reactions to iron or EPO
- •Inability to complete outcome assessments (i.e. not expected to survive hospitalization, unable to make follow-up appointments, non-ambulatory, dementia or other severe cognitive impairment, visual impairment i.e. blind or legally blind)
- •Pregnancy or breastfeeding at time of enrollment
- •Inability to receive pharmacologic venous thromboembolic prophylaxis except in patients with recent surgical or gastrointestinal bleeding
- •Active or suspected thrombosis (i.e. deep venous thrombosis, pulmonary embolism, acute arterial thrombus within 3 months)
- •Uncontrolled sepsis (i.e. <48 hours of appropriate antimicrobial therapy and/or lack of definitive source control)
- •Having received ≥10 units of allogeneic RBCs in the 48 hours before enrollment
- •Acute coronary syndrome or ischemic stroke within 3 months
- •Weight less than 40 kg
- •Concerns with study enrollment expressed by the clinical team
- •Mechanical circulatory support devices
研究组 & 干预措施
Anemia Treatment Bundle
The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).
干预措施: Iron Dextran (Drug)
Anemia Treatment Bundle
The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).
干预措施: Erythropoietin (EPO) (Drug)
结局指标
主要结局
Hemoglobin Concentrations
时间窗: 1 month post-hospitalization
Hemoglobin is a protein that cares oxygen through the body
次要结局
- Hemoglobin Concentrations(Hospital discharge (approximately 1 month), 3 months post-hospitalization)
- Phlebotomy Practice-Blood Draws(Hospital discharge (approximately 1 month))
- Phlebotomy Practice-Volume(Hospital discharge (approximately 1 month))
- Unplanned Hospital Readmissions(3 months and 12-months post-hospitalization)
- Mortality(3 months and 12-months post-hospitalization)
- Adverse Events Post-enrollment(Hospital discharge (approximately 1 month), 3-months post-hospitalization)
- Accelerometry-measured Number of Steps Taken Per Day(1 and 3-months post-hospitalization)
- Accelerometry-measured Daily Maximum Step Cadence(1 month and 3 month post hospitalization)
- Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)(Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization)
- Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale(Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization)
- 6 Minute Walk Distance(1 and 3-months post-hospitalization)
- Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)(1 and 3-months post-hospitalization)
- Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS)(1 and 3-months post-hospitalization)
- Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)(1 and 3-months post-hospitalization)
- Number of Participants With Allogeneic Red Blood Cell Transfusions(3-months post-hospitalization)
- Number of Transfused Units of Allogeneic Red Blood Cells(3 months post hospitalization)
研究者
Matthew A. Warner
Principal Investigator
Mayo Clinic