NCT00299949

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
The University of Texas Health Science Center, Houston·ClinicalTrials.govTerminated
View on ClinicalTrials.gov
Study focus
Study type
Observational
Sponsor & location
Primary sponsor
The University of Texas Health Science Center, Houston
Location
Houston, United States of America
Timeline & enrollment
Phase
N/A
Start date
Oct 01, 2006
End date
Dec 01, 2008
Enrollment
2 participants
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
Disseminated intravascular coagulation of fetus and newbornDisseminated intravascular coagulation [defibrination syndrome]Sepsis, unspecifiedOther specified sepsisOther sepsis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT00299949
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT00299949 through Pure Global AI's free database. This phase not specified trial is sponsored by The University of Texas Health Science Center, Houston and is currently Terminated. The study focuses on Sepsis,Disseminated Intravascular Coagulation. Target enrollment is 2 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.