Why the study?
In vitro thrombogenicity studies for blood-recirculating devices are not standardized, complicating comparisons across devices and driving reliance on in vivo models during pre-clinical development.
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May guide preclinical device testing standards; leaves open consensus protocols to reduce in vivo reliance.
In general, researchers have favored in vivo models to thoroughly evaluate thrombosis, limiting in vitro evaluation to hemolysis. In vitro studies are not standardized and it is often difficult to compare studies on similar devices. As blood-recirculating devices have advanced to include wearable and implantable artificial organs, expanded guidelines standardizing in vitro testing are needed to identify the thrombotic potential without excessive use of in vivo resources during pre-clinical development.
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Sarode et al. (2019) studied this question.
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