Clinical Application of Red Blood Cell Suspension, Obtained From the Pathogen Reduced Whole Blood in Children With Oncological and Hematological Diseases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- intertransfusion interval
研究概览
简要总结
The aim of the study is to evaluate the effectiveness and safety of the application of pathogen inactivated RBC suspension in children with oncological and hematological diseases.
详细描述
Assumed scope of study:
The study will include 70 patients: 35 patients to the test group, who will get transfusions with pathogen-inactivated red blood cell suspension; 35 patients to the control group, who will get transfusions with irradiated red blood cell suspension.
Methods:
- Selection of patients suitable to participate in the study.
- A few days before the assumed transfusion date, select/prepare a red blood cell suspension corresponding to ABO and Rh systems, with no more than 14 days of storage. Conduct direct antiglobuline test (DAT), indirect antiglobuline test (IAT) and test for individual compatibility with the patient's serum.
- Before performing transfusion (on the day of transfusion), determine the initial indices of the patient (Hb, Hct, Haptoglobin). Determine the red blood cell suspension indices (Hb, Hct, extracellular potassium, free hemoglobin, hemolysis percentage).
- Perform transfusion. Evaluate the presence and severity of post-transfusion reactions and complications.
- Measure the patient's Hb, Hct, potassium and haptoglobin levels the next day after the transfusion.
- Perform DAT 3 to 5 five days after the transfusion.
- Perform IAT 2 to 3 weeks after the transfusion.
- Evaluate the need for transfusions over the follow-up period (30 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need supportive transfusion therapy with RBC suspension
排除标准
- •Active bleeding
- •Sepsis/severe infection (any infectious disease requiring pressor agents, infusion and respiratory support)
- •Positive DAT and / or IAT before transfusion
- •Double populations for ABO and RH blood group antigens
- •Severe hepatomegaly/splenomegaly
- •Patients receiving chemotherapy (at the time of need for transfusion)
- •Patients receiving antithymocyte immunoglobulin and also within 7 days after its completion
- •Patients requiring transfusion of only irradiated blood components
研究组 & 干预措施
Riboflavin+UV RBC
35 patients who met all inclusion and exclusion criteria received transfusion with RBC suspension from whole blood, treated with riboflavin and ultraviolet pathogen reduction technology
干预措施: Riboflavin+UV RBC (Biological)
irradiated RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
干预措施: irradiated RBC (Biological)
结局指标
主要结局
intertransfusion interval
时间窗: 1 months
Evaluate the need for transfusions over the follow-up period (30 days)
augmentation of hemoglobin
时间窗: 24 hours after transfusion
Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion
post-transfusion reactions
时间窗: 24 hours after transfusion
evaluate the presence and severity of post-transfusion reactions and complications.
sensitization
时间窗: 2-3 weeks after transfusion
perform indirect antiglobuline test
augmentation of hematocrit
时间窗: 24 hours after transfusion
Measure the patient's hematocrit (%) the next day after the transfusion
immune responses
时间窗: 3-5 days after transfusion
Perform direct antiglobuline test
次要结局
未报告次要终点