Genetic Polymorphisms & The Risk for Sepsis After Trauma

Trauma Clinical Trial

Official title:

Genetic Polymorphisms & The Risk for Sepsis After Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021552
• Other study ID #: 44109-A
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: December 5, 2016
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.

Description:

The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Admitted to the Intensive Care Unit (ICU) at Harborview Medical Center after suffering a traumatic injury

• ability to obtain a 5 ml blood sample

• Expected to be in the ICU for more than 24 hours

Exclusion Criteria:

• We will exclude subjects with chronic medical conditions for the reasons stated above as well as vulnerable populations (children, pregnant females, and prisoners)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Trauma
• Wounds and Injuries

Intervention

Other:
• blood sampling
5 ml blood sampling

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigators aim to identify up to 100 single-nucleotide polymorphisms (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.	The investigators will be studying whether baseline genetic difference can be used in the future to identify patients at high risk and conversely those at low risk for complicated post-traumatic infections.	3 years	No