Clinical trial NCT04834713: Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS
Official title: Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhagic Fever With Renal Syndrome
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: Changes in the platelet activation ratio, %
timeFrame: through study completion, an average of 2 year
measure: Changes in neutrophils MPO content, MFI
timeFrame: through study completion, an average of 2 year
measure: Changes in the neutrophils with adherent platelets, %
timeFrame: through study completion, an average of 2 year
measure: Changes in the neutrophils with internalized platelets, %
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Changes in Neutrophils Mac-1 expression, MFI
timeFrame: through study completion, an average of 2 year
measure: Changes in the platelets with phosphatidylserine exposure,%
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong university
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: xiaojiao Li
role: STUDY_DIRECTOR
References: