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
1 other identifier
observational
2
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2006
CompletedFirst Posted
Study publicly available on registry
March 7, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFebruary 8, 2013
February 1, 2013
2.2 years
March 3, 2006
February 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
ETP will be used to predict 28 day mortality
28 days
Eligibility Criteria
Patients arriving in Emergency Department with sepsis (systemic inflammatory response syndrome).
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Biospecimen
Samples will be discarded after the study is completed.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah L. Brown, M.D.
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Pediatrics
Study Record Dates
First Submitted
March 3, 2006
First Posted
March 7, 2006
Study Start
October 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
February 8, 2013
Record last verified: 2013-02