Multiple TraumaNCT02398175
Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome
An observational study of Multiple Trauma, run by Medical University of Vienna.
Trial summary
The present study predicts that concomitant chest injuries in polytraumatized pediatric patients are a potential source of substantial morbidity and mortality. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Multiple Trauma
- What is being tested?
- reanimation/intubation
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All pediatric (age < 18 years) polytrauma patients with associated thoracic injuries, admitted to this Level I Trauma center, between January 1992 and December 2008
Who may be able to join
- Children with isolated, but severe and potentially life-threatening injuries ISS ≥16 injuries to only one body cavity together with a single long bone fracture thoracic injuries
Who cannot join
- Injury Severity Score (ISS) of < 16 age >18 no thoracic injuries
About this study
The present study predicts that concomitant chest injuries in polytraumatized pediatric patients are a potential source of substantial morbidity and mortality.
- Conditions
- Multiple Trauma
- Being tested
- reanimation/intubation
- Keywords
- Pediatric polytrauma, thoracic injuries
- Medical subject headings
- Multiple Trauma, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reanimation/intubationOther
| Study group | Role | What they receive |
|---|---|---|
| Pediatric polytraumatized patients with thoracic injuries | Pediatric polytraumatized patients (age < 18), (ISS > 16) with thoracic injuries Receives: Other: reanimation/intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury Severity Score
Measured: at least one year follow up
Thoracic Injuries
Thoracic injuries and outcome ( number of participants with Thoracic Injuries, type of injury)
Measured: at least one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startJan 2008
- Primary completionJan 2015
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398175
- Sponsor's protocol ID
- 2008
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome
- ClinicalTrials.gov ID
- NCT02398175
- Acronym / sponsor ID
- 2008
- Conditions
- Multiple Trauma
- Keywords
- Pediatric polytrauma, thoracic injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2015 (actual)
- First posted
- 25 Mar 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.
The present study predicts that concomitant chest injuries in polytraumatized pediatric patients are a potential source of substantial morbidity and mortality.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric polytraumatized patients with thoracic injuries | – | Other: reanimation/intubationPediatric polytraumatized patients (age < 18), (ISS > 16) with thoracic injuries |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pediatric (age < 18 years) polytrauma patients with associated thoracic injuries, admitted to this Level I Trauma center, between January 1992 and December 2008
Key inclusion criteria (1 listed)
- Children with isolated, but severe and potentially life-threatening injuries ISS ≥16 injuries to only one body cavity together with a single long bone fracture thoracic injuries
Key exclusion criteria (1 listed)
- Injury Severity Score (ISS) of < 16 age >18 no thoracic injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reanimation/intubation | Other | Pediatric polytraumatized patients with thoracic injuries |
Primary outcome
Injury Severity Score
Time frame: at least one year follow up
Thoracic Injuries
Time frame: at least one year follow up
Thoracic injuries and outcome ( number of participants with Thoracic Injuries, type of injury)
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 25 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma, run by Medical University of Vienna.
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 1 inclusion and 1 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Injury Severity Score (time frame: at least one year follow up). The study lists 2 primary outcomes in all. 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 25 Mar 2015.