Diagnosis of Lung Complication After Allo-HSCT by Multiple Parameter System Through BAL
SHSYXY-BAL
1 other identifier
observational
250
0 countries
N/A
Brief Summary
The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedStudy Start
First participant enrolled
August 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedAugust 9, 2019
August 1, 2019
2.6 years
August 8, 2019
August 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate
Efficiency of treatment for pulmonary complications after allo-HSCT
100 days after BAL
Secondary Outcomes (2)
microbiology diagnostic yields
100 days after BAL
all-cause mortality and attributable mortality of pulmonary complications
30-day and 100-day after BAL
Study Arms (1)
BAL group
Adult patients with hematology disease under allo-HSCT at any phase of treatment are enrolled according to the following criteria: 1. lung infiltration detection at computed tomography (CT) scan. 2. Patients with fever, cough, respiratory symptoms. According to the investigators, the patients fulfilling these criteria undergo BAL as soon as possible
Interventions
The diagnostic yield of different diagnostic methods for lung infection and non-infectious diseases under allo-HSCT patients. 1. Classic microbiological cultures designed for bacteria, fungi, and mycobacteria. 2. Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit. 3. Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method. 4. Cytological and pathogenic microscopic evaluation in BALF 5. Flow cytological analysis of T lymphocyte subsets in BALF and serum 6. Cytokine detection in BALF and serum 7. Microbiology detection in BALF by mNGS
Eligibility Criteria
High morbidity and mortality in patient receiving hematopoietic Stem Cell Transplantation (HSCT) are resulted from lung complications. Diagnosis of the etiology affects the choice of treatment. The bronchoalveolar lavage (BAL) analysis is safe and widely accepted, which provide valuable information for pathogen identification in pulmonary infections diagnosis.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Shen Z, Wang Y, Bao A, Yang J, Sun X, Cai Y, Wan L, Huang C, Xu X, Niu J, Xia X, Shen C, Wei Y, Qiu H, Zhou K, Zhang M, Tong Y, Song X. Metagenomic Next-Generation Sequencing for Pathogens in Bronchoalveolar Lavage Fluid Improves the Survival of Patients with Pulmonary Complications After Allogeneic Hematopoietic Stem Cell Transplantation. Infect Dis Ther. 2023 Aug;12(8):2103-2115. doi: 10.1007/s40121-023-00850-w. Epub 2023 Aug 4.
PMID: 37541984DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xianmin song, M.D.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 100 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 8, 2019
First Posted
August 9, 2019
Study Start
August 30, 2019
Primary Completion
March 30, 2022
Study Completion
March 30, 2022
Last Updated
August 9, 2019
Record last verified: 2019-08