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Indicators of Inflammation and Coagulation in Sepsis

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ClinicalTrials.gov Identifier: NCT01128283
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : September 12, 2014
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma

Brief Summary:
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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Temporal Behavior of Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis
Study Start Date : January 2002
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Patients with severe sepsis
ICU patients without evidence of infection

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

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01128283     History of Changes
Other Study ID Numbers: 09681
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes