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Diagnosis of Lung Complication After Allo-HSCT by Multiple Parameter System Through BAL

Diagnosis of Lung Complication After Allogeneic Hematopoietic Stem Cell Transplantation by Multiple Parameter System Through Bronchoscopic Alveolar Lavage

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04051372
Acronym
SHSYXY-BAL
Enrollment
250
Registered
2019-08-09
Start date
2019-08-30
Completion date
2022-03-30
Last updated
2019-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoalveolar Lavage Fluid, Lung Infection

Keywords

Idiopathic Pneumonia Syndrome, CMV Pneumonia, Pneumocystis Jiroveci Pneumonia, Invasive Pulmonary Aspergillosis

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.

Detailed description

一) 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 二) The BALF samples were tested using such methods 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 三) Pathogenic spectrum analysis and Targeted etiological therapy

Interventions

DIAGNOSTIC_TESTBronchoscopic Alveolar Lavage

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

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosed with hematological diseases. 2. Recipients of allogeneic peripheral blood stem cell transplantation. 3. Lung infiltration detection at computed tomography (CT) scan. 4. Patients with fever, cough, respiratory symptoms. 5. Consent to BAL and follow-up observation after BAL

Exclusion criteria

1. Severe bleeding tendency, platelet less than 20000/uL, or severe coagulation dysfunction; 2. Multiple bullae are at risk of rupture; 3. Untreated patients with active pulmonary tuberculosis; 4. Patients with severe consumptive diseases or conditions and various causes can not cooperate well 5. Cardiac insufficiency, severe pulmonary ventilation dysfunction 6. Recent massive hemoptysis 7. Aortic aneurysm and esophageal varices are at risk of rupture

Design outcomes

Primary

MeasureTime frameDescription
overall response rate100 days after BALEfficiency of treatment for pulmonary complications after allo-HSCT

Secondary

MeasureTime frameDescription
microbiology diagnostic yields100 days after BALComparing the pathogenic detection rate by BALF with non-invasive detection method
all-cause mortality and attributable mortality of pulmonary complications30-day and 100-day after BAL30-day and 100-day mortality (including all-cause mortality and attributable mortality of pulmonary complications) in patients undergoing BAL

Contacts

Primary Contactxianmin song, M.D.
shongxm@139.com86-21-37798987
Backup Contactsu li
lisuabcd@126.com86-21-37798987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026