Thrombin Generation and Thromboelastography in Non-overt DIC
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ClinicalTrials.gov Identifier: NCT00299949
Recruitment Status :
(Insufficient subject enrollment)
First Posted : March 7, 2006
Last Update Posted : February 8, 2013
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Deborah Brown, The University of Texas Health Science Center, Houston
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.
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients arriving in Emergency Department with sepsis (systemic inflammatory response syndrome).
Systemic inflammatory response syndrome with known or suspected infection
Patient to be admitted to the hospital
Diabetic ketoacidosis, Hemophilia, weight < 25 kg, use of hemostatic agents prior to entry.