Patient-Driven Transfusion Thresholds in Hematological Disorders: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03.
研究概览
简要总结
This pilot study evaluates safety of administration of red blood cell transfusions requested by patients based on their symptoms instead of levels of hemoglobin for the treatment of chronic anemia in patients with blood disorders.
详细描述
PRIMARY OBJECTIVE:
I. To assess feasibility and safety of red blood cell transfusions at the time subjects requested based on symptomatic anemia.
SECONDARY OBJECTIVES:
I. To define a patient-driven red blood cell transfusion (RBCT) threshold and to compare the median hemoglobin (hgb) at the time subjects request RBCT to the standard threshold of hgb < 8 g/dL.
II. To compare the number of red blood cell (RBC) units transfused and the frequency of transfusions at the time subjects request RBCT during the study period to the number of RBC units received and frequency using the standard threshold hemoglobin < 8 g/dL during a comparable period prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hematological malignancy or marrow failure syndrome such as but not limited to: aplastic anemia, myelodysplastic syndrome or leukemia
- •Chronic transfusion-dependent anemia with exposure to at least 5 RBCT
- •Interested in reducing transfusion exposure
- •Willing to sign informed consent
排除标准
- •Recent acute bleeding requiring intervention in less than 24 hours
- •Hemoglobin levels < 6 g/dL
- •Acute leukemia receiving induction chemotherapy
- •Any patient with known ischemic heart disease, history of congestive heart failure, history of stroke, or cardiac arrhythmia for which the patient requires medication or a medical device
- •Oxygen dependent
- •Oxygen saturation below 92% on room air
- •Receiving erythropoietin stimulating agent
- •Thalassemia major or sickle cell disease requiring blood transfusion
- •Undergoing major surgery
- •Hemolytic anemia
- •Coagulopathies including disseminated intravascular coagulation (DIC), receiving anticoagulant or antiplatelet agents
- •Diagnosed with chronic obstructive pulmonary disease (COPD) oxygen dependent
- •Pregnancy
- •Participation in a therapeutic clinical trial
结局指标
主要结局
Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03.
时间窗: Up to 6 months of study participation
Frequency, duration, and severity of AEs and severe adverse events will be determined. The proportion of subjects with serious side effects will be calculated with 95% confidence interval. Descriptive statistics will be used to characterize subjects enrolled on the trial: age, sex, race and diagnosis.
次要结局
- Frequency of RBC units transfused(Up to 6 months of study participation)
- Hemoglobin concentration at the time subject requests RBCT(Up to 6 months of study participation)
- QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time subjects request RBCT(Up to 6 months of study participation)
- Number of RBC units transfused(Up to 6 months of study participation)
- QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time hemoglobin is 8 +/- 0.5 g/dL(Up to 6 months of study participation)
研究者
Ana G. Antun, MD
Principal Investigator
Emory University