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Indicators of Inflammation and Coagulation in Sepsis

This study has been completed.
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma Identifier:
First received: May 20, 2010
Last updated: September 11, 2014
Last verified: September 2014
We will collect blood samples from patients with the diagnosis of sepsis and other ICU patients. We will describe the course of different mediator levels and organ injury markers and follow their progression throughout the course of the study.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Temporal Behavior of Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis

Resource links provided by NLM:

Further study details as provided by Gary Kinasewitz, University of Oklahoma:

Primary Outcome Measures:
  • Death [ Time Frame: 30 days ]
    Survival at 30 days

Biospecimen Retention:   Samples Without DNA

Enrollment: 500
Study Start Date: January 2002
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Patients with severe sepsis
ICU patients without evidence of infection

Detailed Description:
After informed consent is obtained 5 cc of blood is collected on the day of admission and on days 0, 1, 3, and 7 thereafter. Plasma is collected and frozen for the subsequent measurement of biomarkers.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients

Inclusion Criteria:

  • Admission to the ICU

Exclusion Criteria:

  • No blood draws scheduled
  • Hemoglobin level < 6,5 gm/dl
  Contacts and Locations
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Please refer to this study by its identifier: NCT01128283

United States, Oklahoma
OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Gary T. Kinasewitz, MD University of Oklahoma
  More Information

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma Identifier: NCT01128283     History of Changes
Other Study ID Numbers: 09681
Study First Received: May 20, 2010
Last Updated: September 11, 2014

Keywords provided by Gary Kinasewitz, University of Oklahoma:
organ failure
clotting factors

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on September 20, 2017