Prospective, self-paired clinical study to evaluate the efficacy and safety of blood component separators and single-use centrifugal cup blood component separators

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075390

Enrollment

Unknown

Registered

2023-09-04

Start date

2023-09-06

Completion date

Unknown

Last updated

2023-09-11

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

Conditions

Blood component separator and disposable centrifugal cup blood component separator

Interventions

Experimental group:without

Control group:without

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-55 years old, gender is not limited; (2) Weight: male =50 kg, female =45kg, blood pressure: 90mmHg= systolic blood pressure < 140mmHg /60mmHg= diastolic blood pressure < 90mmHg, pulse pressure difference: =30mmHg, pulse length 60-100 times/min; (3) Hemoglobin (Hb) content for male =120g/L, female =115g/L; (4) Peripheral blood platelet count (PLT) =150×109/L and < 450×109/L, erythrocyte specific volume (HCT) =36%; (5) Voluntarily participate in this clinical trial and sign the subject informed consent.

Exclusion criteria

Exclusion criteria: (1) Taking drugs that inhibit platelet metabolism and affect its function (such as ibuprofen, aspirin, etc.) within 1 week; (2) Patients with an interval of less than 2 weeks for single platelet blood donation, patients with an interval of less than 3 months for whole blood donation, patients with more than 24 times of blood donation in recent 1 year or with a total blood donation volume of more than 10L; (3) serious cardiovascular disease or other organic diseases; (4) Patients with severe liver and kidney dysfunction (AST, ALT or Cr > 1.5 times the upper limit of normal value); (5) Patients with malignant tumors; (6) Allergic to vinyl chloride and ethylene oxide; (7) Pregnant and lactating women, or planned pregnancy within 6 months; (8) Participants who participated in other interventional clinical trials within 3 months before the start of this trial; (9) Others deemed unsuitable for clinical trials by the investigator.

Design outcomes

Primary

Measure	Time frame
Platelet concentration;percentage plate recovery;Platelet enrichment factor;	—

Secondary

Measure	Time frame
The concentration of different types of white blood cells;Hemoglobin concentration;Platelet activity;Growth factor concentration;Pipeline performance pass rate;Equipment performance;	—

Countries

China

Contacts

Public Contactzhupeiyuan

Nanjing Hospital of Traditional Chinese Medicine

zhupy@njucm.edu.cn+86 139 5180 0956

Outcome results

None listed

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