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Completed

NCT Number: NCT02508272

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.

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Key information

Conditions

Trauma Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Division of Trauma Surgery

Zurich, CH-8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Systemic Inflammation and Sepsis

    Time frame: 21 days after trauma

Secondary outcomes

  1. Mortality

    Time frame: 28 days after Trauma

  2. Nosocomial infections

    Time frame: 21 days after trauma

  3. SOFA score

    Time frame: 21 days after trauma

  4. Systemic inflammation score

    Time frame: 21 days after trauma

  5. Hospital length of stay

    Time frame: 28 days after trauma

  6. ICU length of stay

    Time frame: 28 days after trauma

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Jul 24, 2015
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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