Hemolytic anemia
Conditions
Interventions
Gold Standard:The RBCS-01A Erythrocyte Life Span Tester (Guangdong medical device registration certificate number 20162220292) produced by Shenzhen Seekya Bio-Sci & Tech Co., Ltd. was used to detect t
Index test:WY-2201 Red Blood Cell Life Span Breath Analyzer
Sponsors
923rd Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army.
Eligibility
Sex/Gender
All
Age
7 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 7-75 years old, male or female; (2) Those who intend to undergo red blood cell life measurement, including but not limited to people who have a physical examination and need to be diagnosed differentially, and the source is outpatient or inpatient; (3) Subjects and/or guardians voluntarily participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe cardiopulmonary insufficiency; (2) Received blood transfusion within 1 week prior to the test of this clinical trial; (3) Suffering from respiratory infectious diseases, such as influenza, tuberculosis, etc.; (4) Long-term smoking (smoking index = 400) or long-term exposure to second-hand smoke (daily exposure to second-hand smoke for = 1 hour, and exposure to second-hand smoke for = 10 years); (5) Pregnant or lactating women, and those who cannot rule out the possibility of pregnancy; (6) Those who have participated in other drugs, medical devices and other related clinical trials within the past 3 months before the clinical trial; (7) Those who are considered by the investigator to be unsuitable to participate in this clinical trial, including but not limited to: mental illness and cognitive dysfunction, inability to understand the informed consent form, poor compliance, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| red blood cell life span determination;Detection concordance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection accuracy;Device performance evaluation;Usability evaluation; | — |
Countries
China
Contacts
Public ContactXiaolin Yin
Department of Hematology, 923rd Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army.
Outcome results
None listed