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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhagic Fever With Renal Syndrome
• Intervention / Treatment: Other: clinical classification of HFRS

• Study Type: Observational
• Enrollment (Anticipated): 28

Contacts and Locations

• Study Contact: Name: Xiaojiao Li; Phone Number: 0086-17521011271; Email: lixiaojiao@xjtufh.edu.cn
• Study Contact Backup: Name: lin Su; Phone Number: 0086-18280308359; Email: linsu0218@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiaotong University
      • Contact: Xiaojiao Li; Phone Number: 0086-17521011271; Email: lixiaojiao@xjtufh.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This project intends to collect about 160 inpatients (the First Affiliated Hospital of Xi'an Jiaotong University) who were diagnosed with HFRS between 2021.01-2023.06 for follow-up research, including about 40 cases of light, medium, severe, and critical. 40 healthy people served as normal controls.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Director: xiaojiao Li, First Affiliated Hospital of Xian Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2020
• Primary Completion (ANTICIPATED): February 28, 2024
• Study Completion (ANTICIPATED): February 28, 2024

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Hematologic Diseases; Blood Platelet Disorders; Bunyaviridae Infections; Hantavirus Infections; Thrombocytopenia; Hemorrhagic Fevers, Viral; Hemorrhagic Fever with Renal Syndrome
• Other Study ID Numbers: XJTU1AF-CRF-2020-013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No