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NCT00299949 · ClinicalTrials.gov registry record

Thrombin Generation and Thromboelastography in Non-overt DIC

A clinical trial, sponsored by The University of Texas Health Science Center, Houston.

Terminated
Registry status
2
Enrollment target

NCT00299949: Clinical Trial study, sponsored by The University of Texas Health Science Center, Houston.

NCT00299949 is a clinical trial that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00299949 was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.

TERMINATED
Registry status
2 participants
Enrollment target

Study 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.

Primary Outcome

ETP will be used to predict 28 day mortality

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2006-10
Est. Completion 2008-12

Why NCT00299949 stopped before completion

NCT00299949 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00299949 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00299949 about?

NCT00299949 is a clinical study titled "Thrombin Generation and Thromboelastography in Non-overt DIC". 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 th...

What is the current status of trial NCT00299949?

This trial is currently terminated. The enrollment target is 2 participants. The study started on 2006-10. Estimated completion is 2008-12.

Who is sponsoring clinical trial NCT00299949?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00299949, the US trial registry maintained by the National Library of Medicine. NCT00299949 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.