Designing Future Clinical Trials for Sepsis-associated Disseminated Intravascular Coagulation

Abstract

Defining success in a clinical trial is not necessarily a straightforward task, especially when the target population is critically ill patients where few agents have demonstrated effectiveness. This has been the case for trials of anticoagulation in patients with sepsis-associated disseminated intravascular coagulation (DIC), which have generally examined patients with severe sepsis but not specifically DIC. Limitations of existing studies include inadequate anticoagulant doses and delayed initiation of treatment. Furthermore, 28-day mortality has been adopted as the primary endpoint but is affected by a panoply of factors other than anticoagulant therapies and may not be the most relevant measure. Future trials must address several current limitations in order to improve our understanding of the role of anticoagulation in patients with sepsis-associated DIC.

Determining prognostic indicator for anticoagulant therapy in sepsis-induced disseminated intravascular coagulation

“…The aim of this study is to develop and validate a prognostic index identifying 28-day mortality in septic DIC patients treated with antithrombin concentrate after a 3-day treatment. We expect a composite indicator built on multiple factors, such as improvement in organ dysfunction and DIC score, to be helpful for that purpose [ 7 ]. The advantage of this evaluation method is that it allows us to design the endpoint to assess treatment effects within a relatively short time period [ 8 ].…”