Thrombin Generation and Thromboelastography in Non-overt DIC

This study has been terminated.
(Insufficient subject enrollment)
Sponsor:
Information provided by (Responsible Party):
Deborah Brown, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00299949
First received: March 3, 2006
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition
Sepsis
Disseminated Intravascular Coagulation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Whole Blood and Cell-rich Coagulation Assays for the Detection of Non-Overt DIC in Sepsis

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    ETP will be used to predict 28 day mortality


Biospecimen Retention:   Samples Without DNA

Samples will be discarded after the study is completed.


Enrollment: 2
Study Start Date: October 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients arriving in Emergency Department with sepsis (systemic inflammatory response syndrome).

Criteria

Inclusion Criteria:

  • Systemic inflammatory response syndrome with known or suspected infection
  • Patient to be admitted to the hospital

Exclusion Criteria:

  • Diabetic ketoacidosis, Hemophilia, weight < 25 kg, use of hemostatic agents prior to entry.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00299949

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Deborah L. Brown, M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Deborah Brown, Associate Professor, Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00299949     History of Changes
Other Study ID Numbers: HSC-MS-06-0012
Study First Received: March 3, 2006
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sepsis
Disseminated Intravascular Coagulation
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia

ClinicalTrials.gov processed this record on October 19, 2014