Continuous Infusion of Granulocyte Colony-stimulating Factor is Associated With an Advantage in Neutrophil Recovery in Hematologic and Oncologic Disorders
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absolute neutrophil counts (ANC)
研究概览
简要总结
The investigators hypothesized that in terms of granulocyte colony-stimulating factor (G-CSF) administration, the route of continuous infusion would lead to a faster neutrophil recovery compared to that of bolus administration
详细描述
The investigators aimed to enroll 40 hospitalized patients in this phase 4 clinical trial. Patients with an ANC lower than 500 cells/mm3 will be randomly categorized into experimental and controlled arms. The experimental arm was designed to receive G-CSF intravenous infusion for 5 hours at a dose of 5 mcg/kg. The controlled arm was designed to receive a G-CSF bolus injection within one minute at a dose of 5 mcg/kg. Three days after treatment initiation, serum white blood cell and differential counts will be followed daily to determine the timing of steady neutrophil recovery. In the following time of another neutropenia event, the experimental arm would cross-switch to the controlled arm and receive corresponding G-CSF according to the study design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
We aimed to enroll 40 hospitalized patients in this phase 4 clinical trial. Patients with an ANC lower than 500 cells/mm3 will be randomly categorized into experimental and controlled arms. The experimental arm was designed to receive G-CSF intravenous infusion for 5 hours at a dose of 5 mcg/kg. The controlled arm was designed to receive a G-CSF bolus injection within one minute at a dose of 5 mcg/kg. Three days after treatment initiation, serum white blood cell and differential counts will be followed daily to determine the timing of steady neutrophil recovery. In the following time of another neutropenia event, the experimental arm would cross-switch to the controlled arm and receive corresponding G-CSF according to the study design.
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with an age between 0 to 18 years old will be included
- •Hematologic and oncologic malignancies
排除标准
- •Patients with a diagnosis of myelodysplastic syndrome or severe aplastic anemia will be excluded
- •Patients receiving G-CSF treatment 7 days before enrollment will be excluded
- •Patients concurrently receiving cytokine therapy or thrombopoietin receptor agonist therapy will be excluded
研究组 & 干预措施
Experimental Group
G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours
干预措施: G-CSF administration (bolus injection versus intravenous infusion) (Drug)
Control Group
G-CSF at a dose of 5 mcg/kg/day intravenously bolus
干预措施: G-CSF administration (bolus injection versus intravenous infusion) (Drug)
结局指标
主要结局
Absolute neutrophil counts (ANC)
时间窗: up to 30 days
ANC higher than 1500 cells/mm3 for three consecutive days
次要结局
- Re-hospitalization event(up to 5 times)
- Hospitalization duration(up to 30 days)
- Clinical sepsis(up to 5 times)
研究者
Yi-Lun Wang
Medical doctor/Clinical physician
Chang Gung Memorial Hospital