TraumaNCT02508272
Transcriptomic Profiling in Severely Injured Patients
An observational study of Trauma and Inflammation, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Inflammation, Sepsis
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2009to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trauma patients with systemic inflammation due to multiple injuries (Polytrauma: ISS ≥ 17 points)
Who may be able to join
- patient age ≥18 y
- Injury Severity Score (ISS) ≥ 17 points
- time from injury to admission < 6 h.
Who cannot join
- Moribund Patients with:
- PH < 7,1 or
- Lactate > 15 mmol/l or
- Base deficit > 15 mEq/l
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Trauma Surgery
Zurich, CH-8091
About this study
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.
Read the 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.
- Conditions
- Trauma, Inflammation, Sepsis
- Keywords
- Transcriptome profiling
- Medical subject headings
- Wounds and Injuries, Inflammation, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients | age ≥18 y ISS ≥ 17 points admission < 6 h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Inflammation and Sepsis
Measured: 21 days after trauma
Secondary outcomes (6)
Mortality
Measured: 28 days after Trauma
Nosocomial infections
Measured: 21 days after trauma
SOFA score
Measured: 21 days after trauma
Systemic inflammation score
Measured: 21 days after trauma
Hospital length of stay
Measured: 28 days after trauma
ICU length of stay
Measured: 28 days after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startDec 2009
- Primary completionMar 2012
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido A Wanner, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508272
- Sponsor's protocol ID
- Stv26/2007
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomic Profiling in Severely Injured Patients
- ClinicalTrials.gov ID
- NCT02508272
- Acronym / sponsor ID
- Stv26/2007
- Conditions
- Trauma, Inflammation, Sepsis
- Keywords
- Transcriptome profiling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients | – | –age ≥18 y ISS ≥ 17 points admission < 6 h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients with systemic inflammation due to multiple injuries (Polytrauma: ISS ≥ 17 points)
Key inclusion criteria (3 listed)
- patient age ≥18 y
- Injury Severity Score (ISS) ≥ 17 points
- time from injury to admission < 6 h.
Key exclusion criteria (4 listed)
- PH < 7,1 or
- Lactate > 15 mmol/l or
- Base deficit > 15 mEq/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic Inflammation and Sepsis
Time frame: 21 days after trauma
6 secondary outcomes
Mortality
Time frame: 28 days after Trauma
Nosocomial infections
Time frame: 21 days after trauma
SOFA score
Time frame: 21 days after trauma
Systemic inflammation score
Time frame: 21 days after trauma
Hospital length of stay
Time frame: 28 days after trauma
ICU length of stay
Time frame: 28 days after trauma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido A Wanner, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Inflammation, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Inflammation and Sepsis (time frame: 21 days after trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.