Genetic Polymorphisms & The Risk for Sepsis After Trauma

December 5, 2016 updated by: Grant E. O'Keefe, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

357

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 998107
        • Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective cohort in which patients with severe injury, defined by combined anatomic injuries sufficient to require admission to the intensive care unit for treatment (blood transfusions, mechanical support of respiration) and intensive monitoring that is expected to be required for more than 24 hours, will be enrolled

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
trauma patients
trauma patients 18 years or older requiring treatment in the ICU >24 hours. All subjects will undergo blood sampling.
Other: blood sampling
5 ml blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Grant O'Keefe, MD, Professor; Dept of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44109-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified samples and data will be available to other investigators at the discretion of the Principal Investigator.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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