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Genetic Polymorphisms & The Risk for Sepsis After Trauma

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ClinicalTrials.gov Identifier: NCT02021552
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Grant E. O'Keefe, University of Washington

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Trauma Other: blood sampling

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 Design
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Study Type : Observational
Actual Enrollment : 357 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Polymorphisms & The Risk for Sepsis After Trauma
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
White blood cells extracted from discarded blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021552


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 998107
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Grant O'Keefe, MD Professor; Dept of Surgery
More Information
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Responsible Party: Grant E. O'Keefe, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02021552    
Other Study ID Numbers: 44109-A
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified samples and data will be available to other investigators at the discretion of the Principal Investigator.
Keywords provided by Grant E. O'Keefe, University of Washington:
Trauma
Sepsis
Additional relevant MeSH terms:
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Sepsis
Wounds and Injuries
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes