SUMMARY

This study endeavors to address the intricate challenges associated with thrombogenicity of materials, particularly in high shear rates environments. The primary objectives encompass understanding the underlying mechanisms of blood clotting, elucidating the relationship between Dr.Ku’s laboratory explanations of clot formation and thrombogenicity, and exploring existing methodologies for assessing thrombogenicity as documented in the literature.

A pivotal aspect of the study involves a novel thrombus circuit designed to replicate high shear rate conditions, providing a platform for comprehensive evaluation of thrombogenic potential. The choices underlying the design and construction of this circuit are outlined, reflecting an effort to enhance thrombogenicity testing protocols.

Collaboration with an external society facilitates the testing of catheters using the newly developed circuit, enabling comparative analysis with data derived from animal studies conducted by the society.

Thrombogenicity endpoints of this study were established according to the expected results from the animal study and the different methodologies in the literature. A comparative analysis between in vitro and in vivo results revealed that the blood loop circuit is a promising predictive tool for assessing thrombogenicity of the porcine study in the specific experimental conditions introduced in this study.

Overall, this master’s thesis not only contributes to advancing my understanding of thrombogenicity testing mechanisms but also suggests a new methodology for thrombogenicity testing.