Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04834713
Collaborator
(none)
28
1
40.6
0.7

Study Details

Study Description

Brief Summary

Thrombocytopenia is an important pathological feature of HFRS(Hemorrhagic Fever With Renal Syndrome, HFRS). However, the cause of thrombocytopenia in HFRS is not yet fully understood. Neutrophils, as the largest number of white blood cells in the human body, can widely participate in the immune process of viral infections. Previous studies have found that the neutrophils of patients with acute myocardial infarction can interact with activated platelets and further mediate platelet phagocytosis.Therefore, this study aims to systematically elucidate the immunological process of neutrophil mediated thrombocytopenia in patients with HFRS by exploring the correlation between platelet activation, neutrophil activation and neutrophil proportion of adherent / phagocytic platelets peripheral blood of HFRS patients, and to analyze its relationship with the course of HFRS disease, which lays a theoretical foundation for further understanding the pathogenesis of HFRS and provides a basis for clinical use.

Condition or Disease Intervention/Treatment Phase
  • Other: clinical classification of HFRS

Study Design

Study Type:
Observational
Anticipated Enrollment :
28 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS
Actual Study Start Date :
Oct 9, 2020
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Mild patients

defined as patients who had kidney injury without oliguria and hypotension

Other: clinical classification of HFRS
Based upon clinical classification of HFRS , the patients were classified into four types

moderate patients

defined as patients who had uremia, effusion (bulbar conjunctiva), hypotension, hemorrhage (skin and mucous membranes), and AKI with typical oliguria

Other: clinical classification of HFRS
Based upon clinical classification of HFRS , the patients were classified into four types

severe patients

defined as patients who had severe uremia, effusion (bulbar conjunctiva and either peritoneum or pleura), hemorrhage (skin and mucous membranes), hypotension and AKI with oliguria (urine output of 50-500 mL/day) for ≤ 5 days or anuria (urine output of < 100 mL/day) for ≤ 2 days

Other: clinical classification of HFRS
Based upon clinical classification of HFRS , the patients were classified into four types

critical patients

defined as patients who usually had one or more of the following complications compared with the severe patients: refractory shock (≥ 2 days), visceral hemorrhage, heart failure, pulmonary edema, brain edema, severe secondary infection, and severe AKI with oliguria (urine output of 50-500 mL/day) for > 5 days or anuria (urine output of < 100 mL/day) for > 2 days

Other: clinical classification of HFRS
Based upon clinical classification of HFRS , the patients were classified into four types

healthy control

defined as people without HFRS

Outcome Measures

Primary Outcome Measures

  1. Changes in the platelet activation ratio, % [through study completion, an average of 2 year]

    flow cytometry

  2. Changes in neutrophils MPO content, MFI [through study completion, an average of 2 year]

    enzyme-linked immunosorbent assay

  3. Changes in the neutrophils with adherent platelets, % [through study completion, an average of 2 year]

    flow cytometry

  4. Changes in the neutrophils with internalized platelets, % [through study completion, an average of 2 year]

    flow cytometry

Secondary Outcome Measures

  1. Changes in Neutrophils Mac-1 expression, MFI [through study completion, an average of 2 year]

    flow cytometry

  2. Changes in the platelets with phosphatidylserine exposure,% [through study completion, an average of 2 year]

    flow cytometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Age ≥18 years;

  • Clinical diagnosis meets the diagnostic criteria of the national HFRS prevention and treatment plan (Hantavirus-specific IgM antibody is positive). The classification and staging standards of HFRS patients are based on the "Expert Consensus of Shaanxi Province on Diagnosis and Treatment of Hemorrhagic Fever with Renal Syndrome".

Exclusion Criteria:
  • Age <18 years;

  • Have a history of kidney disease;

  • Have a history of liver disease;

  • Have a history of malignant tumor;

  • Receive dialysis treatment before admission;

  • Combined with hypertension, coronary heart disease and diabetes history;

  • Combined with HIV infection and patients with autoimmune diseases and pregnancy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Xian Jiaotong university Xi'an Shaanxi China 710061

Sponsors and Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: xiaojiao Li, First Affiliated Hospital of Xian Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT04834713
Other Study ID Numbers:
  • XJTU1AF-CRF-2020-013
First Posted:
Apr 8, 2021
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2021