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Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis (Histone)

This study has been completed.
Oklahoma Medical Research Foundation
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma Identifier:
First received: November 9, 2009
Last updated: April 5, 2012
Last verified: April 2012
In an effort to better understand the interaction between the different mediators, the investigators propose to examine the time course of mediators, the indexes of organ injury and the coagulation cascade.


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

Resource links provided by NLM:

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

Biospecimen Retention:   Samples Without DNA

Enrollment: 500
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

All patients admitted to the ICU (Including VA Medical Center, University Hospital and Presbyterian hospital) will be screened for enrollment in the study. Patients who have the diagnosis of sepsis will be asked to volunteer. We will match sepsis patients with other ICU patients without the diagnosis of sepsis. The latter will also be asked to volunteer.

Patients will be stratified into three groups:

  • Sepsis
  • SIRS of non-septic origin
  • Other ICU patients

Routine laboratory data and clinical data (see flow sheet) will be collected. The plasma or serum will be frozen separately until the target number of patients is met. Measurements of inflammatory mediators and other cytokines/injury markers will be carried out at that point.


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
Patients admitted to the ICU with suspected or proven sepsis.

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: NCT01012115

United States, Oklahoma
OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Oklahoma Medical Research Foundation
Principal Investigator: Gary T Kinasewitz, MD OU Health Sciences Center
  More Information

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma Identifier: NCT01012115     History of Changes
Other Study ID Numbers: 14849
Study First Received: November 9, 2009
Last Updated: April 5, 2012

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

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on September 19, 2017