NCT05761457招募中不适用
Efficacy and Safety of Autologous Cryopreserved Platelets in Patients With Platelet Refractoriness
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of adverse events after blood transfusion
研究概览
简要总结
The purpose of this study is to improve the platelet level of PTR patients; Prevent and improve bleeding; Help patients to successfully through the bone marrow suppression period after chemotherapy; Reduce the overall rate of PTR and allo-immunity; Saving platelet resources and reducing blood burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ALL，AML，MDS, CML,CLL that suffered from PTR before, with or without HLA antibodies
- •The platelet level >150*10E9/L when considering autologous PLT collection
- •Age less than 70 years
- •The expected life more than 3 months
- •Agree to receive autologous platelet cryopreservation and infusion treatment, and sign the informed consent form
排除标准
- •Blast cells are found in peripheral blood or bone marrow
- •Patients with bacteremia or sepsis
- •Coagulation function abnormality
- •Patients who have a history of thrombosis and are receiving anticoagulant treatment
- •Severe bleeding within 2 weeks
- •Participate in another clinical study within 1 month, and have treatment with potential impact on platelets
- •Patients with mental disease
结局指标
主要结局
Incidence of adverse events after blood transfusion
时间窗: 1 hour
The frequency or number of effective infusions (1h CCI>7.5, 24h CCI>4.5)
时间窗: 24 hours after transfusion
Corrected count increment，CCI
The total platelet transfusion volume
时间窗: 1 month
The CCI value of 1h and 24h after cryopreserved autologous platelet transfusion
时间窗: 24 hours after transfusion
Platelet level detection
次要结局
- Time of platelet recovery after chemotherapy(1 month)
- The overall incidence of PTR(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Freeze-deried (FD) PRP for bone engineeringalveolar bone atrophy-JPRN-jRCTs072180076Asahina Izumi5
已完成
不适用
Efficacy of freeze-dried platelet-rich plasma (FD-PRP) in bone engineering: Pilot studyalveolar bone atrophyJPRN-UMIN000027144Department of Regenerative Oral Surgely, Nagasaki University Graduate School of Biomediacal Sciences5
已完成
不适用
rhTPO Mobilized Auto Cryo Platelets For GYN Patients Receiving CarboplatinNeoplasms, GynecologicNCT00038012M.D. Anderson Cancer Center33
已完成
1 期
Study on the Safety and Efficacy of Cryopreserved Platelets in Hypoproliferative Thrombocytopenic PatientsHypoproliferative ThrombocytopeniaNCT05067608Singapore General Hospital17
已完成
1 期
A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen SclerosusVulvar Lichen SclerosusNCT04967170Jennifer R. Arthurs30