Hemophagocytosis in Critically Ill Adult Patients With Cytopenias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF)
研究概览
简要总结
The purpose of the study is to find out whether non-responsiveness to therapeutic recombinant human granulocyte colony-stimulation factor (rhG-CSF) is associated with hemophagocytosis in critically ill adult patients with cytopenias.
详细描述
In children with bi- or pancytopenia, hemophagocytosis is known as life-threatening hemophagocytic lymphohistiocytosis (HLH). The purpose of the study is to find out whether adult patients with bicytopenia or pancytopenia fulfilling the clinical HLH criteria used in children reflect life-threatening hemophagocytosis and whether hemophagocytosis is associated with responsiveness to recombinant human granulocyte colony-stimulation factor (rhG-CSF) or not.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •critically ill adult patients
- •leukopenia and thrombocytopenia
- •rhG-CSF therapy
排除标准
- •life expectancy < 24 hours
- •inclusion in other studies
- •trauma patients with reanimation on scene or immediately dying on hospital admission
- •pregnancy
- •hematologic disorder, malignancy
- •high dose corticosteroid treatment or chemotherapy
结局指标
主要结局
responsiveness to recombinant human granulocyte colony-stimulating factor (rhG-CSF)
时间窗: within 7 days
increase in leukocytes
次要结局
- 8 clinical HLH criteria(7 days)
研究者
Manfred Weiss
Professor, MD, MBA
University of Ulm