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.
Researchers across various disciplines are conducting clinical trials in COVID-19, and because they are not attuned to collecting these data we are seeing ranges of incidences. ASH RC and ISTH developed this toolkit to harmonize data collection and help all clinical researchers speak the same language. Standardizing how thrombosis is defined and measured across all COVID-19 trials will give us a more complete picture of the magnitude of risk - who is experiencing blood clots, what predisposes them to clotting - which could lead to the development of more targeted interventions and treatments."
Stephanie Lee, MD, MPH, of Fred Hutchinson Cancer Research Institute and President, American Society of Hematology (ASH), 2020 ASH RC President
While abnormal blood clotting is an established complication of COVID-19, particularly in hospitalized patients, the precise incidence, risk factors, and natural history of these events remains uncertain due to inconsistencies in how studies are being designed and conducted. As a result, it has been challenging to apply clinical insights from studies into practice. To address this issue, the ASH RC and ISTH established uniform definitions of thrombosis-related outcomes for incorporation into COVID-19 clinical trials addressing a diverse range of interventions.
"The ISTH is pleased to collaborate with ASH on this important initiative, and we encourage investigators to use this toolkit, which will standardize data collection and allow for better comparison of findings across trials," said Jeffrey Weitz, MD, ISTH President. "The collaboration utilized the recently approved ISTH Common Data Elements for venous thromboembolism, supporting the ISTH CDE project's goal of establishing a consistent vocabulary for clinical research."
The toolkit includes a customizable range of options for maximal flexibility, from a limited set of essential variables to a comprehensive set of clinical and biological variables, including variable definitions, permissible values, and measurement tools and units.
Depending on the individual study objectives, design, and available resources, investigators can select from three levels of detail in seven domains: venous thromboembolism, myocardial infarction, stroke/transient ischemic attack, peripheral artery thrombosis, bleeding, laboratory investigations, and antithrombotic therapy.
This turnkey solution is designed to create efficiency in study design and implementation by providing a pre-established, standardized set of variables vetted by individuals with expertise in thrombosis and hemostasis and clinical trial development.