Genetic Polymorphisms & The Risk for Sepsis After Trauma

NCT02021552 | Completed

• 1 other identifier: 44109-A
• Study Type: observational
• Target: 357
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

Trauma; Sepsis

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (1)

trauma patients

trauma patients 18 years or older requiring treatment in the ICU \>24 hours. All subjects will undergo blood sampling.

Other: blood sampling

Interventions

blood sampling OTHER

5 ml blood sampling

trauma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 998107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

White blood cells extracted from discarded blood samples

MeSH Terms

Conditions

Wounds and Injuries; Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Grant O'Keefe, MD

  Professor; Dept of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 27, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)