Randomized Multicenter Trial of Two Transfusion Strategies for Patient Receiving Chemotherapy for Acute Leukemia or Hematopoietic Stem Cells With Medico-economic Evaluation of Cost Minimization.
试验速览
- 阶段
- 3 期
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Number of severe complications (grade 3 or more)
研究概览
简要总结
Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit hematology require compensation of anemia and thrombocytopenia by blood transfusions of red blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g / dL. These recommendations allow to transfuse a single RBP for very elderly patients or in cases of associated heart disease (heart failure). A recent development (2012) on post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk patients.
More recently, a Swiss team has historically compared transfusion policies in 2 139 patients with hematological malignancies. The first group received 2 RBP transfusion in case of symptomatic anemia or hemoglobin level <6 g / dL. The other group only received 1 RBP at each transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP transfusion policy has resulted in a 25% decrease in the number of RBP used without any complication. In a prospective single-center pilot study, we showed that transfusing a single RBP was possible without increasing the side effects of anemia, without complications and allow an overall reduction in consumption of red blood cell units.
Several meta-analyzes reported in intensive care or bleeding situations that a restrictive use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and mortality. The number of patient to be treated to prevent one death is 33.
The main objective is to demonstrate in a randomized trial that the restrictive strategy (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are performed in case of hemoglobin level <8g/dL.
Key secondary objectives are to reduce the number of RBP used and the cost of hospitalization with a comparison of complications/mortality in the 2 groups.
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
- •Inpatients with either acute leukemia patient receiving intensive chemotherapy or autologous transplantation for lymphoma, allogeneic stem cell transplantation
排除标准
- •ischemic heart failure
- •acute promyelocytic leukemia
- •ALKERAN autologous conditioning (myeloma patient)
- •disseminated intravascular coagulation
- •hemorrhagic syndrome
- •any vital distress at diagnosis
- •creatinine clearance <50 ml/min
- •liver disease with ALT (alanine aminotransferase)/AST(aspartate aminotransferase) ≥2.5 ULN (upper limit of normal) (except if related to tumor)
- •pregnant female
- •autoimmune hemolytic anemia
研究组 & 干预措施
ARM A
Two packed red blood cells will be transfused in patient with anemia defined as a hemoglobin level below 8 g / dL. Clinical and biological monitoring will be carried out later each day. If the hemoglobin is <8 g / dL, two new packed red blood cells are transfused and so on.
干预措施: Two packed red blood cells Transfusion (Drug)
ARM B
Single red blood packed cells Transfusion will be administered in patient with anemia defined as a hemoglobin level below 8 g/dL. Clinical and biological monitoring will be carried out later each day. If the hemoglobin is <8 g / dL, a single unit is transfused and so on.
干预措施: Single red blood packed cells Transfusion (Drug)
结局指标
主要结局
Number of severe complications (grade 3 or more)
时间窗: up to 1 month after the last day of hospitalization
complications are defined as: stroke, transient ischemic attack, acute coronary syndrome, heart failure, arrhythmias or conduction cardiac disease, deep vein thrombosis, pulmonary embolism, elevated troponin, transfer to intensive care unit, death from any cause, new or progressive radiographic infiltrates, infections related to transfusion.
次要结局
- number of RBP transfused(up to 1 month after the last day of hospitalization)
- Incidence of bleeding(up to 1 month after the last day of hospitalization)
- Time to erythroid recovery(up to 1 month after the last day of hospitalization)
- time of aplasia(up to 1 month after the last day of hospitalization)
- Transfusion performance(up to 24 hours)
- Quality of life(up to 1 month after the last day of hospitalization)
- Failure to respect the randomisation arm(up to 1 month after the last day of hospitalization)
- Transfusion related events(up to 1 month after the last day of hospitalization)
- transfusion in out patient(up to 1 month after the last day of hospitalization)