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 because the information has not been verified recently.
Verified September 2010 by Hallym University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01211899
First received: September 29, 2010
Last updated: October 4, 2011
Last verified: September 2010
  Purpose

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.


Condition
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted to the ICU for severe sepsis or septic shock

Criteria

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

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01211899     History of Changes
Other Study ID Numbers: f2000tj2
Study First Received: September 29, 2010
Last Updated: October 4, 2011
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2014