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

NCT ID: NCT04834713

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-09
• Study Completion Date: 2024-02-28

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Mild patients

defined as patients who had kidney injury without oliguria and hypotension

clinical classification of HFRS

Intervention Type: OTHER

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

clinical classification of HFRS

Intervention Type: OTHER

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

clinical classification of HFRS

Intervention Type: OTHER

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

clinical classification of HFRS

Intervention Type: OTHER

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

healthy control

defined as people without HFRS

No interventions assigned to this group

Interventions

clinical classification of HFRS

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

xiaojiao Li

Role: STUDY_DIRECTOR

First Affiliated Hospital of Xian Jiaotong University

Locations

First Affiliated Hospital of Xian Jiaotong university

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaojiao Li

Role: CONTACT

lixiaojiao@xjtufh.edu.cn

0086-17521011271

lin Su

Role: CONTACT

linsu0218@163.com

0086-18280308359

Facility Contacts

Xiaojiao Li

Role: primary

lixiaojiao@xjtufh.edu.cn

0086-17521011271

Other Identifiers

XJTU1AF-CRF-2020-013

Identifier Type: -

Identifier Source: org_study_id