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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04834713
Other study ID # XJTU1AF-CRF-2020-013
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Enrolling by invitation NCT00623168 - Ribavirin for Hemorrhagic Fever With Renal Syndrome Phase 2