Removal of activated leukocytes from the blood during extracorporeal circulation surgery reduces the inflammatory respons
Conditions
Interventions
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age > = 18 years old and < = 75 years old, gender is not limited; 2. Cardiovascular surgery is planned, and CPB is required during the operation; 3. Understand the purpose of this trial and voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Emergency surgery or heart transplant surgery. 2. Systemic infection confirmed by pathogenic examination of blood samples (such as pathogen nucleic acid detection, isolation and culture, etc.) before surgery. 3. Preoperative inactivity of vital organs such as heart, lungs, kidneys, etc., requiring mechanical assisted ventilation, mechanical assisted circulatory support (such as IABP, ECMO, left ventricular assist device, etc.) or blood purification therapy. 4. Circulatory surgery is expected to be required during the operation. 5. Known history of allergy to polyester materials or silicone and other test device materials. 6. Combined immune system diseases, including autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.) and diseases that cause immune deficiency (such as AIDS, hematologic malignant tumors, etc.). 7. Receiving immunosuppressive or corticosteroid therapy, oral prednisone > 0.5mg/kg/d or equivalent. 8. Known history of heparin-induced thrombocytopenia. 9. Preoperative coagulation dysfunction, prolonged APTT or PT and > 1.5 times the upper limit of normal. 10. Preoperative platelet count < 75×10^9/L. 11. Pregnant and lactating females. 12. Combined with severe mental disorders, unable to understand and cooperate with clinical trials. 13. The group had participated in other interventional clinical trials in the previous 3 months. 14. The investigator believes that it is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Instant activation of leukocyte removal rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute kidney injury;Incidence of respiratory dysfunction;Incidence of stroke;Incidence of cardiovascular complications;All cause mortality;Circulatory support drugs;SOFA score;Relative change rate of total white blood cells;Cytoinflammatory factor concentration;Postoperative mechanical ventilation time;ICU stay time;Postoperative hospitalization time; | — |
Countries
China
Contacts
Public ContactZhang Weizhi
Xiangya Second Hospital of Central South University
Outcome results
None listed