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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemorrhagic Fever With Renal Syndrome

Intervention / Treatment
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* Other: clinical classification of HFRS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild patients<br>defined as patients who had kidney injury without oliguria and hypotension | Other: clinical classification of HFRS<br>* Based upon clinical classification of HFRS , the patients were classified into four types<br>|
| moderate patients<br>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<br>* Based upon clinical classification of HFRS , the patients were classified into four types<br>|
| severe patients<br>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<br>* Based upon clinical classification of HFRS , the patients were classified into four types<br>|
| critical patients<br>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<br>* Based upon clinical classification of HFRS , the patients were classified into four types<br>|
| healthy control<br>defined as people without HFRS | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Neutrophils Mac-1 expression, MFI | flow cytometry | through study completion, an average of 2 year | 
| Changes in the platelets with phosphatidylserine exposure,% | flow cytometry | through study completion, an average of 2 year |