Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis: a Multi-center, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.
研究概览
简要总结
Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria:
- •Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
- •Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc
排除标准
- •Exclusion Criteria Subjects who meet one of the following criteria will not be enrolled:
- •Patients with liver cirrhosis, liver cancer, and hepatic encephalopathy
- •Patients with trauma, hepatosplenic rupture and other organ hemorrhage
- •Patients with severe disease such as shock, sepsis, and multiple organ failure
- •Patients with DIC
- •Patients with long-term anemia
- •Patients with acute promyelocytic leukemia
- •Patients with idiopathic deafness
- •Patients who have taken hormones/immunosuppressants 72 hours before admission
- •Hereditary fibrinogen deficiency
研究组 & 干预措施
Screening patients with suspected hemophagocytic syndrome
Preliminary screening of patients with elevated ferritin and low fibrinogen, and then continue to improve triglycerides, abdominal color ultrasound and other examinations to further clarify, for some very suspicious patients, timely improve genes, NK cell activity and other tests, as soon as possible to determine whether they are patients with hemophagocytic syndrome
干预措施: Patients diagnosed with HLH-94 should be treated as soon as possible (Drug)
结局指标
主要结局
The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.
时间窗: Time forecasting:2 years
次要结局
未报告次要终点