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Development of a rapid clinical detection kit for activated leukocytes

Development of a rapid clinical detection kit for activated leukocytes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092645
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Immune cells

Interventions

Gold Standard:The expression of classic activation antibodies on the surface of leukocytes detected by flow cytometry is diagnosed as activated leukocytes. For example, neutrophils with surface CD11b(
Index test:Expression of fibrin on the surface of activated leukocytes

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients undergoing cardiac surgery with cardiopulmonary bypass; 2) Aged 18-75 years, regardless of gender; 3) Understand the purpose of this trial and voluntarily participate, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Pregnant or breastfeeding women; 2) Participation in other interventional clinical trials within 30 days prior to surgery or during hospitalization; 3) Comorbid immune system diseases, including but not limited to AIDS, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, nephrotic syndrome, rheumatoid arthritis, multiple sclerosis, myasthenia gravis, scleroderma, Crohn's disease, ulcerative colitis; use of immunosuppressive drugs within six months prior to admission, including monoclonal antibodies, polyclonal antibodies, antimetabolites, alkylating agents, microbial metabolites; or receiving radiation therapy; 4) Presence of malignant tumors in any location; 5) Presence of hematological diseases, including but not limited to aplastic anemia, thalassemia, acute lymphoblastic leukemia, acute myeloid leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia; or comorbid other severe coagulopathy disorders, and currently undergoing anticoagulation therapy; 6) History of organ transplantation or bone marrow transplantation; 7) Unable to obtain informed consent.

Design outcomes

Primary

MeasureTime frame
Fibrin-positive cells;

Secondary

MeasureTime frame
Activated leukocytes;

Countries

China

Contacts

Public ContactLei Du

West China Hospital, Sichuan University

dulei@scu.edu.cn+86 189 8090 1926

Outcome results

None listed

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