A Multi-center, Single-blind, Randomized, Parallel, Non Inferiority Study to Separately Investigate the Effect of Standard Platelets Versus Platelets Prepared With Two Commercial Procedures of Pathogen Reduction Technologies (PRT) on Bleeding Incidence and Severity in Thrombocytopenic Recipients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 456
- 试验地点
- 9
- 主要终点
- Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets
研究概览
简要总结
Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. The two technologies will be analyzed separately.
Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets.
Secondary endpoints: time to the first grade 2 or greater bleeding event after the first study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of days with grade 2 or greater bleeding during the period of platelet transfusion support; number of platelet units transfused and total dose of platelets transfused per day of thrombocytopenic platelet support; proportion of patients with acute transfusion reactions; post-transfusion platelet count increments
Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization, frequency of clinical refractoriness to platelet transfusion with demonstrated HLA alloimmunization, frequency of clinical refractoriness to platelet transfusion that is persistent during the period of platelet support in the absence of HLA or human platelet antigen (HPA) alloimmunization
Patients will be evaluated for 4 weeks after randomization.
详细描述
When patient's platelet count, done in early morning every day, falls below 10000/microliter, physician in charge issues a platelet transfusion request to transfusion service. Transfusion service (which knows patient treatment arm) issues a PRT product or a standard product as indicated, typically within hours of request receipt; patient's physician identifies unit code and intended recipient's code and determines vital signs (pulse, blood pressure, body temp). Transfusion is started and completed in 30 min. Adverse reactions are monitored by ward personnel and once a day IPTAS local coordinator visits the ward, checks IPTAS patients' records, fills IPTAS forms, examines and interviews each enrolled patient and transfers filled forms to data coordinating center in Milan.
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
- Single (Outcomes Assessor)
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
- •adults (> 18 years)
- •a hematooncology diagnosis (includes patients newly diagnosed and previously diagnosed)
- •expected to require 2 or more PLT transfusions in 4 weeks
- •hospital admission (patients admitted to out-patient clinics will not be enrolled)
- •chemotherapy, related and matched unrelated donor (MUD)transplant recipients
- •recurrent auto-transplanted patients, requiring chemotherapy
- •negative pregnancy test in female patients less than 60 years old
排除标准
- •presence of HLA class I abs on admission with PRA >20%
- •historical documented record of 2 or more 1 hour post-TX PLT corrected count increments <5,000 per microliter
- •previously included in IPTAS
- •diagnosis of a solid tumor
研究组 & 干预措施
Standard platelets
Transfusion
干预措施: Platelet transfusion (Procedure)
Pathogen reduced platelets
Transfusion
干预措施: Platelet transfusion (Procedure)
结局指标
主要结局
Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets
时间窗: Within 4 weeks after randomization
次要结局
- Number of days with grade 2 or greater bleeding during the period of platelet transfusion support(Within 4 weeks after randomization)
- Post-transfusion platelet count increments(Within 4 weeks after randomization)
- Proportion of patients with acute transfusion reactions(Within 4 weeks after randomization)
- Total dose of platelets transfused per day of thrombocytopenic platelet support(Within 4 weeks after randomization)
- Time to the first grade 2 or greater bleeding event after the first study transfusion(Within 4 weeks after randomization)
- Proportion of transfusions given to treat breakthrough bleeding(Within 4 weeks after randomization)
- Number of platelet units transfused per day of thrombocytopenic platelet support(Within 4 weeks after randomization)