Hemorrhagic Fever With Renal SyndromeNCT04834713
Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS
An observational study of Hemorrhagic Fever With Renal Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Fever With Renal Syndrome
- What is being tested?
- clinical classification of HFRS
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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".
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong university
Xi'an, Shaanxi, 710061
Xiaojiao Li, 0086-17521011271, lixiaojiao@xjtufh.edu.cn
About this study
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
- Being tested
- clinical classification of HFRS
- Medical subject headings
- Hemorrhagic Fever with Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical classification of HFRSOther
Based upon clinical classification of HFRS , the patients were classified into four types
| Study group | Role | What they receive |
|---|---|---|
| Mild patients | defined as patients who had kidney injury without oliguria and hypotension Receives: 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 Receives: 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 Receives: 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 Receives: Other: clinical classification of HFRS | |
| healthy control | defined as people without HFRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the platelet activation ratio, %
flow cytometry
Measured: through study completion, an average of 2 year
Changes in neutrophils MPO content, MFI
enzyme-linked immunosorbent assay
Measured: through study completion, an average of 2 year
Changes in the neutrophils with adherent platelets, %
flow cytometry
Measured: through study completion, an average of 2 year
Changes in the neutrophils with internalized platelets, %
flow cytometry
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
Changes in Neutrophils Mac-1 expression, MFI
flow cytometry
Measured: through study completion, an average of 2 year
Changes in the platelets with phosphatidylserine exposure,%
flow cytometry
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start9 Oct 2020
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic Fever With Renal SyndromeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaojiao Li, Study director, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834713
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-013
- Status last verified
- Sep 2021
- First submitted
- 24 Dec 2020
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Neutrophil-mediated Thrombocytopenia and the Condition and the Course of Disease in Patients With HFRS
- ClinicalTrials.gov ID
- NCT04834713
- Acronym / sponsor ID
- XJTU1AF-CRF-2020-013
- Conditions
- Hemorrhagic Fever With Renal Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mild patients | – | Other: clinical classification of HFRSdefined as patients who had kidney injury without oliguria and hypotension |
| moderate patients | – | Other: clinical classification of HFRSdefined as patients who had uremia, effusion (bulbar conjunctiva), hypotension, hemorrhage (skin and mucous membranes), and AKI with typical oliguria |
| severe patients | – | Other: clinical classification of HFRSdefined 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 |
| critical patients | – | Other: clinical classification of HFRSdefined 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 |
| healthy control | – | –defined as people without HFRS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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".
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical classification of HFRSBased upon clinical classification of HFRS , the patients were classified into four types | Other | Mild patients, critical patients, moderate patients, severe patients |
Primary outcome
Changes in the platelet activation ratio, %
Time frame: through study completion, an average of 2 year
flow cytometry
Changes in neutrophils MPO content, MFI
Time frame: through study completion, an average of 2 year
enzyme-linked immunosorbent assay
Changes in the neutrophils with adherent platelets, %
Time frame: through study completion, an average of 2 year
flow cytometry
Changes in the neutrophils with internalized platelets, %
Time frame: through study completion, an average of 2 year
flow cytometry
2 secondary outcomes
Changes in Neutrophils Mac-1 expression, MFI
Time frame: through study completion, an average of 2 year
Changes in the platelets with phosphatidylserine exposure,%
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaojiao Li study director
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhagic Fever With Renal Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaojiao Li (0086-17521011271, lixiaojiao@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the platelet activation ratio, % (time frame: through study completion, an average of 2 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.