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

NCT04834713 | Unknown

• 1 other identifier: XJTU1AF-CRF-2020-013
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Fever With Renal Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Changes in Neutrophils Mac-1 expression, MFI

  through study completion, an average of 2 year

• Changes in the platelets with phosphatidylserine exposure,%

  through study completion, an average of 2 year

Study Arms (5)

Mild patients

defined as patients who had kidney injury without oliguria and hypotension

Other: clinical classification of HFRS

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

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

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

healthy control

defined as people without HFRS

Interventions

clinical classification of HFRS OTHER

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

Mild patients; critical patients; moderate patients; severe patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong university

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Fever with Renal Syndrome

Condition Hierarchy (Ancestors)

Hantavirus Infections; Bunyaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Study Officials

• xiaojiao Li

  First Affiliated Hospital of Xian Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

xiaojiao Li

CONTACT

0086-17521011271; lixiaojiao@xjtufh.edu.cn

lin Su

CONTACT

0086-18280308359; linsu0218@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: April 8, 2021
• Study Start: October 9, 2020
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

CN (1)