Skip to content

Evaluation of the Effects of a Single-Use Activated Leukocyte Adsorption Device on Immune Cell Profiling and Function in Patients Undergoing Cardiopulmonary Bypass: A Prospective Observational Study

Evaluation of the Effects of a Single-Use Activated Leukocyte Adsorption Device on Immune Cell Profiling and Function in Patients Undergoing Cardiopulmonary Bypass: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600130989
Enrollment
Unknown
Registered
2026-08-27
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-31

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

Conditions

Systemic inflammatory response induced by systemic inflammatory response

Interventions

Control group:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The original GCP trial, namely the"Clinical trial to evaluate the efficacy and safety of single-use activated leukocyte adsorbers in removing activated leukocytes from blood during cardiopulmonary bypass surgery" (Ethics approval number: 2026 Clinical Trial (Device) Approval No. 7), met the inclusion and exclusion criteria: 2.Able to understand the purpose of the study, voluntarily agree to participate, and provide signed informed consent;

Exclusion criteria

Exclusion criteria: 1. Participants in the original GCP trial, namely the "Clinical trial to evaluate the efficacy and safety of single-use activated leukocyte adsorbents in removing activated leukocytes from blood during cardiopulmonary bypass surgery" (Ethics approval number: 2026 Clinical Trial (Device) Approval No. 7), withdrew their informed consent. 2. The sample size was insufficient; 3. The samples were not stored in accordance with the required standards; 4. The participants had serious complications that affected the testing of immune cells.

Design outcomes

Primary

MeasureTime frame
Immune cell subset proportions and activation status;

Secondary

MeasureTime frame
Changes in the transcriptome and proteome of immune cells;Leukocyte phagocytic function;Concentrations of inflammation-related cytokines;Number of platelet–leukocyte aggregates (PLAs);

Countries

China

Contacts

Public ContactDu Lei

West China Hospital of Sichuan University

dulei@scu.edu.cn+86 28 85422114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026