Establishment and Preliminary Application of an in Vitro Blood Cell Damage Evaluation Test Method for Extracorporeal Membrane Oxygenation
DONG Qi
LI Chengzhi
Ralf BORCHARDT
MENG Chen
YAN Caixia
ZHOU Na
ZHENG Xiu'e
ZHANG Jishun
ZHANG Xiaohan
LIU Xiaoshuai
Abstract：Objective This study aims to establish an in vitro testing method to evaluate the degree of blood cell damage caused by extracorporeal membrane oxygenation(ECMO)kits during use,in order to facilitate preclinical research and product performance assessment.Methods A test circuit was constructed under simulated clinical conditions,and evaluation indicators were established based on relevant standards and guidelines,including free hemoglobin(FHb),index of hemolysis(IH),platelet decline rate,and leukocyte decline rate.The ECMO kit was used to operate this test method,with samples collected at 0 h,0.5 h,3 h,and 6 h during the test.Results An experimental method for testing blood cell damage induced by ECMO kits was estab-lished,with the HI as an evaluation indicator for blood cell damage.Calculation formulas for the increase in free hemoglobin,and the decline rates of platelets and leukocytes were developed.The established method was applied to test the ECMO kit,which showed an increase in free hemoglobin levels and a decrease in platelet and leukocyte counts during the testing process.Specif-ically,the increase in free hemoglobin was 44～80 mg/(L·h),the platelet decline rate was 1.7%/h～27.8%/h,and the leukocyte decline rate was 1.5%/h～16.3%/h.Conclusion The in vitro testing method established in this study provides a scientific tool for evaluating overall blood cell damage caused by ECMO kits,improving the accuracy of test results and supporting the preclin-ical assessment of product safety and efficacy.
Keywords：extracorporeal membrane oxygenationblood cell damagefree hemoglobinhemolysis indexplatelet de-cline rateleukocyte decline rate
Publication Date：2025-12-28
Online Publishing Date：2026-01-16(First online date of this platform, not the publication date of the document)
Pages：5( 522-526 )