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
• Interventions: Other: clinical classification of HFRS

• 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

Arm && Interventions

Group	Intervention	Description
Mild patients	clinical classification of HFRS	defined as patients who had kidney injury without oliguria and hypotension
critical patients	clinical classification of HFRS	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
moderate patients	clinical classification of HFRS	defined as patients who had uremia, effusion (bulbar conjunctiva), hypotension, hemorrhage (skin and mucous membranes), and AKI with typical oliguria
severe patients	clinical classification of HFRS	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

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