Thrombin Generation and Thromboelastography in Non-overt DIC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299949
Recruitment Status : Terminated (Insufficient subject enrollment)
First Posted : March 7, 2006
Last Update Posted : February 8, 2013
Information provided by (Responsible Party):
Deborah Brown, The University of Texas Health Science Center, Houston

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.

Condition or disease
Sepsis Disseminated Intravascular Coagulation

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 2 participants
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
Study Start Date : October 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Primary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
    ETP will be used to predict 28 day mortality

Biospecimen Retention:   Samples Without DNA
Samples will be discarded after the study is completed.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients arriving in Emergency Department with sepsis (systemic inflammatory response syndrome).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299949

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

Responsible Party: Deborah Brown, Associate Professor, Pediatrics, The University of Texas Health Science Center, Houston Identifier: NCT00299949     History of Changes
Other Study ID Numbers: HSC-MS-06-0012
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

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