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Product registration clinical trial of RBCS-01 Erythrocyte Life Span Tester

Product registration clinical trial of RBCS-01 Erythrocyte Life Span Tester

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-17011592
Enrollment
Unknown
Registered
2017-06-07
Start date
2015-01-08
Completion date
Unknown
Last updated
2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemolytic anemia

Interventions

(2)hemoglobin concentration
(3)red blood cell count
(4)the reticulocyte percentage
(8) the plasma free hemoglobin
(11)urinary red blood cells
(12) etiology&#32
Index test:RBCS-01&#32
Life&#32
Span&#32

Sponsors

Southern Medical University Nanfang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Outpatient or inpatient. Hemolytic anemia patients were included in the hemolytic group. Non hemolytic subjects with normal hemoglobin concentration were included in the control group; (2) Between 7~70 years of age, men and women are not limited; (3) No blood transfusion is needed during the clinical trial; (4) Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiopulmonary failure; 2. Pregnant women,lactating women and women who are not pregnant may not be ruled out; 3. Smoking within 24 hours before clinical trials; 4. Blood transfusions were taken 3 weeks before the clinical trial (Except for 7~17 year old volunteers); 5. Volunteers for clinical trials of other drugs, medical devices and other related clinical trials in the past 3 months or are participating; 6. The researchers thought it was inappropriate for volunteers to take part in the clinical trial.

Design outcomes

Primary

MeasureTime frame
HGB;RBC;RET%;IBIL;Peripheral blood smear;Serum haptoglobin;F Hb;URO;BLD;ERY;erythrocyte life span determination;

Countries

China

Contacts

Public ContactQi-fa Liu

Southern Medical University Nanfang Hospital

shawn28@21cn.com+86 18927496007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026