Thrombin Generation and Thromboelastography in Non-overt DIC - Trial NCT00299949

Timeline & Enrollment

Primary Outcome

Mortality

Summary

Sepsis is the 13th most common cause of death in the United States, causing approximately
 210,000 deaths per year. Once DIC has developed, irreversible organ injury has already
 occurred and the mortality rate is 70%. Inhibition of systemic coagulation with activated
 protein C concentrate has been the only therapy for sepsis introduced in the past several
 decades which has improved outcomes. Elucidation of the coagulopathic mechanisms early in the
 development of DIC may give rise to targeted therapies and strategies for early intervention.
 We hypothesize that an increase in endogenous thrombin potential precedes the development of
 overt DIC by a clinically significant time period. Our primary objective is to determine if
 endogenous thrombin potential (ETP) measured at first diagnosis of sepsis prior to the onset
 of DIC and organ failure is predictive of overt DIC and/or poor outcome. We will compare ETP
 to standard coagulation assays and the clinical assessment of DIC using the ISTH criteria for
 overt DIC. A secondary objective of this study is to determine if host coagulation variables
 predispose to the development of DIC and poor clinical outcome during sepsis.

ICD-10 Classifications