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

• Conditions: Hemorrhagic Fever With Renal Syndrome

• Registration Number: NCT04834713
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-09
• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-09
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the platelet activation ratio, %	through study completion, an average of 2 year	flow cytometry
Changes in neutrophils MPO content, MFI	through study completion, an average of 2 year	enzyme-linked immunosorbent assay
Changes in the neutrophils with internalized platelets, %	through study completion, an average of 2 year	flow cytometry
Changes in the neutrophils with adherent platelets, %	through study completion, an average of 2 year	flow cytometry

Secondary Outcome Measures

Name	Time	Method
Changes in the platelets with phosphatidylserine exposure,%	through study completion, an average of 2 year	flow cytometry
Changes in Neutrophils Mac-1 expression, MFI	through study completion, an average of 2 year	flow cytometry

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong university; 🇨🇳 Xi'an, Shaanxi, China