Transcriptomic Profiling in Severely Injured Patients

NCT ID: NCT02508272

Last Updated: 2015-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Inflammation Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trauma patients

age ≥18 y ISS ≥ 17 points admission \< 6 h.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guido A Wanner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Zurich, Division of Trauma Surgery

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Stv26/2007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.