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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 29, 2010
Last Updated Date	October 4, 2011
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01211899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 Gene and Disseminated Intravascular Coagulation in Severe Sepsis and Septic Shock
Official Title ^ICMJE	Incidence and Prognosis of Disseminated Intravscular Coagulation in Patients Severe Sepsis and Septic Shock; Association With 4G/5G Polymorphism of PAI-1 Gene
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Blood sample for 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1)
Sampling Method	Probability Sample
Study Population	Patients admitted to the ICU for severe sepsis or septic shock
Condition ^ICMJE	Severe Sepsis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	160
Completion Date	Not Provided
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01211899
Other Study ID Numbers ^ICMJE	f2000tj2
Has Data Monitoring Committee	Yes
Responsible Party	Hallym University Medical Center
Study Sponsor ^ICMJE	Hallym University Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hallym University Medical Center
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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