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

Hemorrhagic Fever With Renal Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834713
• Other study ID #: XJTU1AF-CRF-2020-013
• Status: Recruiting
• Start date: October 9, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: September 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: xiaojiao Li
• Phone: 0086-17521011271
• Email: lixiaojiao[@]xjtufh.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Fever With Renal Syndrome
• Thrombocytopenia

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the platelet activation ratio, %	flow cytometry	through study completion, an average of 2 year
Primary	Changes in neutrophils MPO content, MFI	enzyme-linked immunosorbent assay	through study completion, an average of 2 year
Primary	Changes in the neutrophils with adherent platelets, %	flow cytometry	through study completion, an average of 2 year
Primary	Changes in the neutrophils with internalized platelets, %	flow cytometry	through study completion, an average of 2 year
Secondary	Changes in Neutrophils Mac-1 expression, MFI	flow cytometry	through study completion, an average of 2 year
Secondary	Changes in the platelets with phosphatidylserine exposure,%	flow cytometry	through study completion, an average of 2 year