Thrombin Generation and Thromboelastography in Non-overt DIC
Stopped early
Conditions studied: Sepsis, Disseminated Intravascular Coagulation
In brief
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.
Key facts
- Study ID
- NCT00299949
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 2
- Starts
- 2006-10-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2013-02-08
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Systemic inflammatory response syndrome with known or suspected infection
- Patient to be admitted to the hospital
You may not qualify if…
- Diabetic ketoacidosis, Hemophilia, weight < 25 kg, use of hemostatic agents prior to entry.
Where it is running
- Memorial Hermann Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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