Effects of Recombinant Human Thrombopoietin on Platelet Levels in ICU Patients With Pneumonia With Thrombocytopenia: a Multicenter, Single-blind, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 178
- 主要终点
- The time to recovery to a normal platelet level
研究概览
简要总结
The incidence of thrombocytopenia in ICU patients with severe illness ranged from 8.3% to 67.6%, and ranged from 14% to 44% during ICU treatment.Severe patients with thrombocytopenia also have significantly increased bleeding events and blood transfusions, and even a significantly increased risk of death.This study examines whether elevated platelets benefit patients with pneumonia
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
- Single (Participant)
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
- •Clinical diagnosis of pneumonia (community acquired pneumonia, hospital acquired pneumonia or ventilator associated pneumonia);
- •Voluntarily signed informed consent;
- •≥18 years old;
- •Platelet count ≤75×109/L
排除标准
- •A history of hematopoietic stem cell transplantation or solid organ transplantation such as liver, kidney or lung;
- •Hematological malignancy;
- •Immune thrombocytopenia, such as SLE, ITP, TTP, etc.
- •The length of stay in ICU is less than 24h;
- •Pregnant or lactation patients;
研究组 & 干预措施
the TPO group
Patients in TPO group will be treated with rhTPO at a dose of 15000u/d, subcutaneous injection, for 7 consecutive days.
干预措施: recombinant human thrombopoietin (Drug)
the control group
Patients in the control group will receive the same amount of saline as a placebo, which is injected subcutaneously, for 7 consecutive days.
干预措施: normal saline (Drug)
结局指标
主要结局
The time to recovery to a normal platelet level
时间窗: 14 days
The clinical recovery time of platelets was defined as the time it takes to reach clinical recovery.
次要结局
未报告次要终点
研究者
Zhenhua Zen
Associate Professor
Nanfang Hospital, Southern Medical University