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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-30

Study Completion Date

2022-03-30

Brief Summary

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The aim of this study was to evaluate the diagnostic yield for lung complication after allo-HSCT by multiple parameter system through BAL.

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Detailed Description

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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

Conditions

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Bronchoalveolar Lavage Fluid Lung Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Bronchoscopic Alveolar Lavage

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Bronchoscopic 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No