Transcriptomic Profiling in Severely Injured Patients

Completed

• Conditions: Inflammation; Trauma; Sepsis

• Registration Number: NCT02508272
• Lead Sponsor: University of Zurich

Brief Summary

Discovery of differences in the host response in patients with systemic inflammation and sepsis, and identification of novel, specific markers by using a longitudinal clinico-transcriptomic approach.

Detailed Description

The aim of this study is to link defined clinical phenotypes with data on RNA obtained from blood samples by high throughput technologies. Genetic and molecular characteristics of the immune system after severe trauma will be crosslinked to clinical aspects of posttraumatic organ failure, with the goal of identifying typical molecular "fingerprints". Patients with and without sepsis or organ failure will be compared with the goal to develop a diagnostic test designed to predict the clinical course following severe trauma. Criteria for study enrollment includes patient age ≥18 y, an Injury Severity Score (ISS) ≥ 17 points, and time from injury to admission \< 6 h. Whole blood from trauma patients will be collected within the first 6 h after trauma (day 0) and on days 1, 2, 3, 5, 7, 10, 14, and 21.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-03
• Status Verified: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-22
• Last Update Submitted: 2015-07-22
• Study First Posted: 2015-07-24
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• patient age ≥18 y
• Injury Severity Score (ISS) ≥ 17 points
• time from injury to admission < 6 h.

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Exclusion Criteria

Moribund Patients with:

• PH < 7,1 or
• Lactate > 15 mmol/l or
• Base deficit > 15 mEq/l

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systemic Inflammation and Sepsis	21 days after trauma

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days after Trauma
Nosocomial infections	21 days after trauma
SOFA score	21 days after trauma
ICU length of stay	28 days after trauma
Systemic inflammation score	21 days after trauma
Hospital length of stay	28 days after trauma

Trial Locations

Locations (1)

University Hospital Zurich, Division of Trauma Surgery; 🇨🇭 Zurich, Switzerland