NCT00299949|Terminated
Study Stopped
Insufficient subject enrollment
Thrombin Generation and Thromboelastography in Non-overt DIC
Use of Whole Blood and Cell-rich Coagulation Assays for the Detection of Non-Overt DIC in Sepsis
Loading search results
Sponsor study identifier
observational
2
1 country
1
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 3, 2006
Actual (reported)March 7, 2006
Actual (reported)October 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 2008
Actual (reported)December 2008
Actual (reported)Mortality
ETP will be used to predict 28 day mortality
28 days
Patients arriving in Emergency Department with sepsis (systemic inflammatory response syndrome).
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Samples will be discarded after the study is completed.
Deborah L. Brown, M.D.
The University of Texas Health Science Center, Houston
2 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2006
First Posted
March 7, 2006
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Last Updated
February 8, 2013
Record last verified: 2013-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: