Combined Platelet Transfusion:A Single-arm, Open, Prospective, Non-inferiority Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- Efficacy evaluation of combined platelet transfusion
研究概览
简要总结
Platelet transfusion is an irreplaceable and important treatment method for clinical prevention and treatment of thrombocytopenia or platelet dysfunction. Due to various factors, it is difficult to achieve platelet ABO complete homotypic transfusion in clinical practice. When ABO-compatible platelets cannot be obtained, plasma-reduced platelets, platelets with low anti-A or anti-B titers are often used in clinical practice to reduce the risk of ABO-incompatible platelet-compatible transfusion reactions. The combined platelets prepared in this study can achieve ABO primary and secondary side compatible infusion.
详细描述
Combined platelet transfusion is a single-arm, open, prospective, non-inferiority study initiated by researchers. Patients with hematological diseases who were admitted to the research unit and applied for platelet transfusion within two years were included in the study after informed consent. When the subjects applied for platelet transfusion during the study period, ABO homotype platelet transfusion was preferred. When there was no ABO homotype platelet in the inventory, ABO primary and secondary side compatible combined platelet transfusion was given. The study period was 2 years, including 15 months of enrollment, 6 months of treatment, and 3 months of follow-up after the end of the treatment period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Aged 18-65 years;
- •Disease treatment in the research hospital;
- •Applied for platelet transfusion therapy.
排除标准
- •1. One month before the start of this study, he participated in other clinical trials of drugs and instruments related to platelet transfusion efficacy;
- •Without platelet transfusion indications;
- •Only received platelet transfusion in the outpatient department and left the hospital without efficacy evaluation after transfusion;
- •Gave up platelet transfusion therapy for any reason after enrollment;
- •Transferred or discharged from hospital for any reason before platelet transfusion after enrollment;
- •Did not receive combined platelet transfusion during the 6-month treatment period after enrollment
研究组 & 干预措施
Experimental group
Combined platelet
干预措施: Combined platelets (Combination Product)
结局指标
主要结局
Efficacy evaluation of combined platelet transfusion
时间窗: From the start of infusion of combined platelets to 6 months later
The platelet count was measured before blood transfusion and 1 hour and 24 hours after blood transfusion, and the WHO bleeding grade was recorded. The platelet incremental correction index ( CCI ) was calculated at 1 hour and 24 hours after infusion. CCI \> 7.5 at 1 hour, CCI \> 4.5 at 24 hours, or the control or improvement of WHO bleeding symptoms after infusion were effective for infusion. CCI = ( PLT after infusion-PLT before infusion ) × body surface area ( m2 ) × 1000 / total platelet count ( × 1011 ), body surface area = 0.0061 × height ( cm ) + 0.0128 × weight ( Kg ) - 0.1529. PPR ( % ) = ( PLT after infusion-PLT before infusion ) × blood volume ( L ) × 100 % / total platelet count × 2 / 3, blood volume = 0.07 × body weight ( Kg ).
次要结局
- Interval time, frequency and total amount of platelet transfusion(From the start of infusion of combined platelets to 6 months later)
- Bleeding adverse events during hospitalization(From the start of infusion of combined platelets to 6 months later)
- Adverse reactions of blood transfusion(From the start of infusion of combined platelets to 6 months later)
- Safety evaluation of combined platelet transfusion(From the start of infusion of combined platelets to 6 months later)
- Platelet antibody screening(From the start of infusion of combined platelets to 6 months later)
- Adverse events of blood transfusion(From the start of infusion of combined platelets to 6 months later)
- Waiting time for platelet transfusion(From the start of infusion of combined platelets to 6 months later)
研究者
zhang li
PHD，Professor
The General Hospital of Western Theater Command