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CompletedNCT01012115HistoneUpdated Apr 9, 2012

Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis

An observational study in Sepsis, sponsored by University of Oklahoma. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-09.

Sponsored by University of Oklahoma · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Sepsis

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Keywords

  • Histones
  • organ failure
  • sepsis
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 500 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • No blood draws scheduled
  • Hemoglobin level \< 6.5 gm/dl
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Biospecimen retention
Samples without dna
06

Study locations

2 sites
  • OU Medical Center
    Oklahoma City, Oklahoma 73104, United States
  • Veterans Affairs Medical Center
    Oklahoma City, Oklahoma 73104, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01012115
Lead sponsor
University of Oklahoma
Collaborators
Oklahoma Medical Research Foundation
Responsible party
Gary Kinasewitz (Principal Investigator, University of Oklahoma) — Principal investigator
First posted
Nov 11, 2009
Start date
Oct 2009
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Apr 9, 2012

Study contacts

Gary T Kinasewitz, MD
principal investigator · OU Health Sciences Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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