Strategies for Transfusion of Platelets (SToP) [Formerly Titled "Evaluation of the Hemostatic Efficacy and Platelet Utilization Rates of Low Versus Standard Dose Platelet Therapy"]
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
研究概览
简要总结
To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.
详细描述
BACKGROUND:Platelet transfusions play a major role in the management of thrombocytopenic patients. Platelet transfusions may be given either in the absence of hemorrhage (prophylactic transfusions), or to control bleeding (therapeutic transfusions). Prophylactic platelet transfusion therapy is most commonly used in patients with decreased marrow platelet production (hypoproliferative thrombocytopenia) and accounts for the majority of platelets transfused to these patients. As platelet use continues to increase at a rate disproportionately higher than that of red cells, it is important to identify the most cost-effective strategies for providing platelet support. The two most important factors - within the control of the ordering physician - that will significantly influence the total amount of platelets transfused are:
- the prophylactic platelet transfusion "trigger" selected for transfusion;
- the number of platelets given per transfusion. The optimal quantity of platelets to be used per transfusion remains a highly controversial subject. No prospective platelet transfusion trials have been performed in which patients are randomized to an assigned platelet dose throughout their period of thrombocytopenia to evaluate the effects of different doses on transfusion outcomes.
INTRODUCTION: A randomized prospective platelet dose trial is proposed to determine a safe, efficient, and cost-effective dosing strategy for transfusing platelets. The trial is designed to answer two fundamental questions: 1) Are low dose platelet transfusions not inferior to standard dose platelet transfusion for patients with chemotherapy induced thrombocytopenia as measured by the frequency of WHO bleeding Grade 2 or greater; and 2) How does the dose of platelets transfused affect the interval between platelet transfusion events, and, thereby, the total number of platelets transfused?
GENERAL OBJECTIVE: To evaluate the hemostatic efficacy of low dose platelet transfusions.
PRIMARY OBJECTIVE: This will be a non-inferiority study designed to determine if low dose prophylactic platelet transfusions can be transfused to patients with chemotherapy induced thrombocytopenia without an increase in the frequency of WHO bleeding (Grade 2 or greater ) when compared to the current transfusion strategy of using standard dose platelet products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypoproliferative thrombocytopenia who are expected to have a platelet count of ≤ 10,000/µL (10x10^9/L) for ≥ 10 days (Note: the prophylactic platelet trigger may be higher than10,000/µL (10x10^9/L) in some participating institutions; however, the patient will still be eligible for participation as long as they are expected to be thrombocytopenic for 10 days)
- •Must be an inpatient.
- •Weight between 40 and 100 kg.
排除标准
- •Diagnosis of promyelocytic leukemia.
- •A history or current diagnosis of immune thrombocytopenia (ITP), thrombotic thrombocytopenia (TTP), or hemolytic uremia syndrome (HUS).
- •Evidence of ≥ WHO Grade 2 bleeding while being assessed for the study entry.
- •Patients who will receive bedside Leukoreduced platelet transfusions.
- •Patients who are pregnant.
结局指标
主要结局
Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
次要结局
- Cost analysis.
- Number of platelets transfused during a defined period of thrombocytopenia
- Number of platelet transfusion events(frequency)
- Number of platelets transfused and frequency per thrombocytopenic day
- Mean duration of thrombocytopenia
- Percentage of days at risk of bleeding
- Differences in the severity of bleeding between treatment groups
- Correlation between the actual platelet dose given per transfusion for each patient and bleeding on the day following transfusion
- Correlation between the actual number between the actual number of platelets transfused/kg body weight for each patient and bleeding on the day following transfusion
- Pre- and post-transfusion bleeding grade in response to the dose of therapeutic platelets transfused
- Surrogate outcomes for hemostatic efficacy including death due to bleeding as the primary and contributory cause of mortality
- Platelet transfusion given above trigger
- Platelet transfusion more often than once a day
- Platelet transfusion given above their assigned dose in each case because of >/= WHO Grade 2 bleeding
- Number of platelets transfused
- Frequency of transfusions and duration of transfusions given because of bleeding
- Total number of RBC transfusions
- The mean per thrombocytopenic day for each patient
- Platelet response (pre-transfusion platelet counts, post-transfusion platelet counts, platelet increments, and corrected platelet count increments (at 1 and/or 24 hours)