Multiple TraumaNCT02030327
Proteomics in Multiple Trauma to Identify Organ Failure
An observational study of Multiple Trauma, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
To analyse differences in protein expression in multiple trauma patients for identification of potential biomarkers to predict organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Trauma
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: older than 18 years multiple trauma patients ISS >16
Who may be able to join
- older than 18 years
- multiple trauma patients
- ISS >16
Who cannot join
- children
- ISS <16
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
Jochen Hinkelbein, MD, +49221478 ext. -97728, jochen.hinkelbein@uk-koeln.de
Jochen Hinkelbein, MD
About this study
Official title: Analysis of Predictive Parameters by Proteomics for Early Diagnosis of Organ Dysfunction in Multiple Trauma Patients - A Pilot Study
To analyse differences in protein expression in multiple trauma patients for identification of potential biomarkers to predict organ dysfunction.
Read the detailed description
The aim of the present study in humans is to analyse differences in protein expression after multiple trauma in patients for identification of potential biomarkers to predict organ dysfunction.
- Conditions
- Multiple Trauma
- Keywords
- proteomics, multiple trauma, organ dysfunction
- Medical subject headings
- Multiple Trauma
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 |
|---|---|---|
| No trauma | n=5 patients | |
| trauma without organ dysfunction | n=40 patients | |
| trauma with organ dysfunction | n=40 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with disease or death vs. healthy
Starting at day O, then every 24 hours until day 20
Measured: Day 0 until day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Hinkelbein, Universitätsklinikum Köln
- Investigators
- Jochen Hinkelbein, MD, Principal investigator, UK Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030327
- Sponsor's protocol ID
- 12-236
- Status last verified
- May 2022
- First submitted
- 2 Jan 2014
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Predictive Parameters by Proteomics for Early Diagnosis of Organ Dysfunction in Multiple Trauma Patients - A Pilot Study
- ClinicalTrials.gov ID
- NCT02030327
- Acronym / sponsor ID
- 12-236
- Conditions
- Multiple Trauma
- Keywords
- proteomics, multiple trauma, organ dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Jan 2014 (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.
To analyse differences in protein expression in multiple trauma patients for identification of potential biomarkers to predict organ dysfunction.
Detailed description
The aim of the present study in humans is to analyse differences in protein expression after multiple trauma in patients for identification of potential biomarkers to predict organ dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No trauma | – | –n=5 patients |
| trauma without organ dysfunction | – | –n=40 patients |
| trauma with organ dysfunction | – | –n=40 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- older than 18 years multiple trauma patients ISS >16
Key inclusion criteria (3 listed)
- older than 18 years
- multiple trauma patients
- ISS >16
Key exclusion criteria (2 listed)
- children
- ISS <16
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
Number of patients with disease or death vs. healthy
Time frame: Day 0 until day 20
Starting at day O, then every 24 hours until day 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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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.
Jochen Hinkelbein, MD principal investigator
UK Köln
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 Multiple Trauma, run by Universitätsklinikum Köln at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with disease or death vs. healthy (time frame: Day 0 until day 20). 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 17 May 2022.