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4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 Gene and Disseminated Intravascular Coagulation in Severe Sepsis and Septic Shock

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Hallym University Medical Center.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: September 30, 2010
Last Update Posted: October 5, 2011
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.
Information provided by (Responsible Party):
Hallym University Medical Center
Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate the incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar coagulatin in patients with severe sepsis and septic shock.

Severe Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Prognosis of Disseminated Intravscular Coagulation in Patients Severe Sepsis and Septic Shock; Association With 4G/5G Polymorphism of PAI-1 Gene

Resource links provided by NLM:

Further study details as provided by Hallym University Medical Center:

Biospecimen Retention:   Samples With DNA
Blood sample for 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1)

Estimated Enrollment: 160
Study Start Date: September 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

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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:   Probability Sample
Study Population
Patients admitted to the ICU for severe sepsis or septic shock

Inclusion Criteria:

  • Adult patinents aged > 18 years, Patients satisfying the criteria by 2008 Surviving Sepsis Campagin, Patients who are determined as having a sepsis within 24 hours of ICU stay

Exclusion Criteria:

  • Do-not-resuscitate, cardiopulmonary resuscitation, ICU stay < 1 day, Refusal to participate in the study, Hematologic malignancy or liver cirrhosis (Child C), Congenital abnormality in coagulation system, Transfer from other ICUs or hospitals
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01211899     History of Changes
Other Study ID Numbers: f2000tj2
First Submitted: September 29, 2010
First Posted: September 30, 2010
Last Update Posted: October 5, 2011
Last Verified: September 2010

Keywords provided by Hallym University Medical Center:
plasminogen activator inhibitor,
disseminated intravascular coagulation,

Additional relevant MeSH terms:
Shock, Septic
Disseminated Intravascular Coagulation
Systemic Inflammatory Response Syndrome
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Plasminogen Inactivators
Plasminogen Activator Inhibitor 1
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors