NCT04051372Unknown不适用
Diagnosis of Lung Complication After Allogeneic Hematopoietic Stem Cell Transplantation by Multiple Parameter System Through Bronchoscopic Alveolar Lavage
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 250 人开始时间: 2019年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- overall response rate
研究概览
简要总结
The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.
详细描述
一) Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria:
- lung infiltration detection at computed tomography (CT) scan.
- Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible
二) The BALF samples were tested using such methods
- classic microbiological cultures designed for bacteria, fungi, and mycobacteria.
- Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit.
- Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method.
- Cytological and pathogenic microscopic evaluation in BALF
- Flow cytological analysis of T lymphocyte subsets in BALF and serum
- Cytokine detection in BALF and serum
- Microbiology detection in BALF by mNGS
三) Pathogenic spectrum analysis and Targeted etiological therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hematological diseases.
- •Recipients of allogeneic peripheral blood stem cell transplantation.
- •Lung infiltration detection at computed tomography (CT) scan.
- •Patients with fever, cough, respiratory symptoms.
- •Consent to BAL and follow-up observation after BAL
排除标准
- •Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction;
- •Multiple bullae are at risk of rupture;
- •Untreated patients with active pulmonary tuberculosis;
- •Patients with severe consumptive diseases or conditions and various causes can not cooperate well
- •Cardiac insufficiency, severe pulmonary ventilation dysfunction
- •Recent massive hemoptysis
- •Aortic aneurysm and esophageal varices are at risk of rupture
结局指标
主要结局
overall response rate
时间窗: 100 days after BAL
Efficiency of treatment for pulmonary complications after allo-HSCT
次要结局
- microbiology diagnostic yields(100 days after BAL)
- all-cause mortality and attributable mortality of pulmonary complications(30-day and 100-day after BAL)
研究者
Xianmin Song, MD
Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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