Transcriptomic Profiling in Severely Injured Patients

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Inflammation; Trauma

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 Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8091
    • University Hospital Zurich, Division of Trauma Surgery

Participation Criteria

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

Trauma patients with systemic inflammation due to multiple injuries (Polytrauma: ISS ≥ 17 points)

Description

Inclusion Criteria:

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

Exclusion Criteria:

Moribund Patients with:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Trauma patients; age ≥18 y ISS ≥ 17 points admission < 6 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Systemic Inflammation and Sepsis	21 days after trauma

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 days after Trauma
Nosocomial infections	21 days after trauma
SOFA score	21 days after trauma
Systemic inflammation score	21 days after trauma
Hospital length of stay	28 days after trauma
ICU length of stay	28 days after trauma

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Guido A Wanner, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Estimate): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Transcriptome profiling
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: Stv26/2007