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The ASH Research Collaborative (ASH RC) and the International Society of Haemostasis and Thrombosis (ISTH), two organizations with multidisciplinary expertise in blood clotting and bleeding disorders, have developed a toolkit to help clinical researchers from across medical disciplines design clinical trials that further the understanding of blood clotting events associated with COVID-19.
The new Toolkit for the Collection of Thrombosis-Related Data Elements in COVID-19 Clinical Studies, published today in Blood Advances, defines a series of endpoints - events or outcomes that are measured in a clinical study - that should be included in study design to collect and analyze important, relevant, and standardized data on dangerous blood clots that form in the veins or arteries of patients with COVID-19. The goal of this initiative is to maximize high-quality collection of COVID-19-associated clotting and bleeding events across diverse medical fields, such as internal medicine, infectious disease, pulmonology, and emergency or critical care medicine, which may capture these events as secondary endpoints or outcomes.