Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm.
研究概览
简要总结
The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.
详细描述
Transfusion of red blood cells (RBCs) is vitally important for the care of patients undergoing myelosuppressive therapy for acute leukemia. The therapeutic approach to this disease involves the use of high doses of chemotherapy to treat the blood cancers and bone marrow disorders; but it damages the marrow and blood system. Malignant and healthy stem cells are affected by the chemotherapy, and even when the malignant cells are killed, it can take weeks for the healthy cells to reconstitute the marrow. At diagnosis and before bone marrow recovery post treatment, RBCs are needed to support the patient. Current practices at major comprehensive cancer centers all utilize liberal hemoglobin transfusions triggers of 8-9 g/dL or higher. Higher hemoglobin levels in these high risk patients may have benefits such as better energy and organ function. However, research in a variety of clinical settings, suggests that a higher hemoglobin transfusion threshold is associated with the same or even higher mortality rates compared to lower hemoglobin thresholds (7-8 g/dL). These other settings include prospective randomized trials in high-risk orthopedic surgery patients, critically ill adult and pediatric ICU patients, acute GI bleed patients, and patients undergoing cardiac surgery. One clinical scenario where the ideal transfusion threshold is unknown is in patients receiving chemotherapy for hematologic malignancies. Transfusion requirements and triggers have not been systematically studied in acute leukemia or other cancers. Acute leukemia carries a high mortality; any unnecessary increase in morbidity or mortality is not acceptable. Without a clear benefit of higher transfusion thresholds, the added risks and costs of transfusion may be substantial and unnecessary. The investigators plan to study this issue in this pilot and feasibility study by randomly assigning patients treated for acute leukemia to be transfused with RBCs at either a higher or lower hemoglobin concentration trigger point. In this way, the investigators will be able to accurately determine if there is benefit or harms to having a lower or higher red cell count during the induction treatment and recovery period for patients with acute leukemias. This study will also collect information evaluating the advantages and disadvantages of the two transfusion thresholds and the feasibility of expanding the study to a large randomized trial.This safety data will serve as a platform for a larger mortality study in leukemia and possibly additional studies in solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Acute leukemia patients (AML, ALL, APL, treatment-related myeloid neoplasm, high grade MDS)
- •Admitted with plans for inpatient myelosuppressive chemotherapy (with standard of care or protocol regimens)
排除标准
- •Age less than 18 years
- •Acute coronary syndrome as defined by active chest pain, dynamic ECG changes, troponin greater than 2.5
- •Active blood loss
- •Receiving erythropoietin stimulating agents prior to admission
- •Chronic Renal Failure in Renal Replacement Therapy
- •Documented wish against transfusion for personal or religious beliefs
研究组 & 干预措施
Low transfusion threshold
Patients receive red blood cell transfusions with a transfusion threshold of 7 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.
干预措施: Red blood cell transfusion (Biological)
High transfusion threshold
Patients receive red blood cell transfusions with a transfusion threshold of 8 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.
干预措施: Red blood cell transfusion (Biological)
结局指标
主要结局
Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm.
时间窗: 60 days
次要结局
- Treatment-related mortality(60 days)
- Safety of low vs. high transfusion threshold as assessed by total difference in number of transfusions given per participant(60 days)
- Safety of low vs. high transfusion threshold as assessed by number of participants experiencing neutropenic infections(60 days)
- Safety of low vs. high transfusion threshold as assessed by number of grade 3-4 bleeding events as defined by CTCAE 4.0(60 days)
- Feasibility as determined by percentage of participants consented(60 days)
- Number of transfusions(60 days)
- Bleeding(60 days)
- Safety of low vs. high transfusion threshold as assessed by number of deaths attributed to induction chemotherapy(60 days)
- Safety of low vs. high transfusion threshold as assessed by number of participants with at least one grade 3-5 non-hematological toxicity by CTCAE 4.0.(60 days)
- Feasibility as determined by percentage of participants who tolerate 7g/dL transfusion(60 days)
- Feasibility as determined by percentage of participants who crossed over from the low arm to the high arm(60 days)
- Neutropenic infections(60 days)
- Length of stay(60 days)
- End organ dysfunction(60 days)
- Performance status scores(60 days)
- Incidence of crossover(60 days)
- Cost savings(60 days)
- Fatigue scores(60 days)