PolytraumaNCT05221476
Red Blood Cell Distribution Width and Charlson Comorbidity Indeces in the Frail Polytraumatized Patient.
An observational study of Polytrauma and Red Blood Cell Distribution Width, run by Medical University of Vienna.
Trial summary
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polytrauma, Red Blood Cell Distribution Width, Comorbidities and Coexisting Conditions
- What is being tested?
- retrospective
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 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: Retrospective analysis of polytraumatized patients.
Who may be able to join
- ISS >16 points
- AIS >3 in one body region
- at least 2 body regions affected
Who cannot join
- patients younger than 18 years of age
- isolated traumatic brain injury
- minor injuries (AIS <3 or ISS <16 points)
About this study
Official title: RDW and CCI in the Frail Polytraumatized Patients. A Retrospective Cohort Study in a Level 1 Trauma Center.
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. RDW values on admission as well as preexisting comorbidities were evaluated.
- Being tested
- retrospective
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospectiveOther
The investigators retrospectively analyzed the short- and long-term outcome in polytraumatized patients and the possible influence of RDW values on admission as well as preexisting comorbidities on these outcomes.
| Study group | Role | What they receive |
|---|---|---|
| polytraumatized patients | Patients with an ISS >16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Receives: Other: retrospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality in polytraumatized patients
Measured: January 2012 to December 2015
Secondary outcomes (1)
Possible influence of RDW values (%) on admission on the long-term outcome
The influence of RDW Values (%) in polytraumatized patients on admission on the long-term outcome (late-phase death (days)) will be examined.
Measured: January 2012 to December 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolytraumaStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Valerie Weihs, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221476
- Sponsor's protocol ID
- RDW Polytrauma
- Status last verified
- Nov 2024
- First submitted
- 8 Jan 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RDW and CCI in the Frail Polytraumatized Patients. A Retrospective Cohort Study in a Level 1 Trauma Center.
- ClinicalTrials.gov ID
- NCT05221476
- Acronym / sponsor ID
- RDW Polytrauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Feb 2022 (actual)
- 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.
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. RDW values on admission as well as preexisting comorbidities were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polytraumatized patients | – | Other: retrospectivePatients with an ISS >16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of polytraumatized patients.
Key inclusion criteria (3 listed)
- ISS >16 points
- AIS >3 in one body region
- at least 2 body regions affected
Key exclusion criteria (3 listed)
- patients younger than 18 years of age
- isolated traumatic brain injury
- minor injuries (AIS <3 or ISS <16 points)
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 |
|---|---|---|
| retrospectiveThe investigators retrospectively analyzed the short- and long-term outcome in polytraumatized patients and the possible influence of RDW values on admission as well as preexisting comorbidities on these outcomes. | Other | polytraumatized patients |
Primary outcome
In-hospital mortality in polytraumatized patients
Time frame: January 2012 to December 2015
1 secondary outcome
Possible influence of RDW values (%) on admission on the long-term outcome
Time frame: January 2012 to December 2015
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 Nov 2024.
- Individual participant dataSharing planned: No
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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 Polytrauma and Red Blood Cell Distribution Width, 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 3 inclusion and 3 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 Nov 2024. 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?
In-hospital mortality in polytraumatized patients (time frame: January 2012 to December 2015). 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 Nov 2024.