NCT01211899

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

October 5, 2011

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

September 29, 2010

Last Update Submit

October 4, 2011

Conditions

Severe Sepsis

Keywords

polymorphism,plasminogen activator inhibitor,disseminated intravascular coagulation,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the ICU for severe sepsis or septic shock

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1)

MeSH Terms

Conditions

SepsisDisseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersThrombophilia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2010

First Posted

September 30, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Last Updated

October 5, 2011

Record last verified: 2010-09