ClinicalTrials.Veeva

Menu

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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Bronchoalveolar Lavage Fluid
Lung Infection

Treatments

Diagnostic Test: Bronchoscopic Alveolar Lavage

Study type

Observational

Funder types

Other

Identifiers

NCT04051372
2018KY270

Details and patient eligibility

About

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

Full 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

Enrollment

250 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

BAL group
Description:
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
Treatment:
Diagnostic Test: Bronchoscopic Alveolar Lavage

Trial contacts and locations

0

Loading...

Central trial contact

su li; xianmin song, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems