Postoperative ComplicationsHELICOPTERNCT06758427
Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation
An observational study of Postoperative Complications and Surgical Site Infection, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu at 1 site in Germany.
Trial summary
At least ten percent of trauma patients suffer from any sort of complication. The study aims to identify a risk factor profile to early identify trauma patients at risk. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Postoperative Complications, Surgical Site Infection, Wound Infection
- How many people
- 2,300 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2025to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 67 years
- All sexes
- Adult, Older adult
Study population: patients that suffer from an acute lone bone fracture, require surgical treatment and belong to the age group of being able to working (18 - 67 years old)
Who may be able to join
- acute long bone fracture (humerus, ulna, radius, femur, tibia) with surgical treatment
Who cannot join
- associated severe injury (ISS > 16)
- associated traumatic brain injury
- associated traumatic spine injury
- dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
At least ten percent of trauma patients suffer from any sort of complication. The study aims to identify a risk factor profile to early identify trauma patients at risk.
Read the detailed description
Trauma patients suffer from a high risk of complications that ranges from soft tissue complications, surgical site infection till bone non-union. Comorbidities are often know to be associated with complications. Also certain blood markers could be identified to be an indicator.
However, certain risk factors have only been investigated in small trauma cohorts so far. This study is a prospective multi center cohort trail that aims to collect all clinical data, comorbidities, medication, blood markers in trauma patients after long bone fractures. In a 6 months and one year follow up patients with complications will be identified. Methods of machine learning will help to identify a risk factor profile for certain groups of patients with complications.
The aim of the study is to early identify patients at risk for a complication after trauma according to their blood marker, clinical, comorbidity and medication profile.
- Conditions
- Postoperative Complications, Surgical Site Infection, Wound Infection, Non-healing Wound, Pseudarthrosis, Bone Infection
- Keywords
- long bone fracture, trauma
- Medical subject headings
- Postoperative Complications, Surgical Wound Infection, Wound Infection, Pseudarthrosis, Pneumonia, Cross Infection, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
any complication after long bone fracture
number of patients that suffer from a complication after surgical treatment of a primary long bone fracture
Measured: 6 months, one year
Clavien Dindo Classification
Clavien Dindo Classification classifies surgical complications. All patients will be classified according to Clavien Dindo after 6 months and one year.
Measured: 6 months, one year
Secondary outcomes (4)
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index classifies comorbidities of patients. All particiapants will be screened for their comorbidities and classified according to CCI.
Measured: Initially
number of medications
Intake of medication will be assessed and number of medication will be identified.
Measured: initally
EuroQual 5 Dimensions Questionnaire (EQ5D5L)
EQ5D5L will be assessed from each participant to identify their quality of life.
Measured: initially, 6 months, one year.
patient reported outcome measure associated with the lone bone fracture
patient reported outcome measure will be assessed by each patient that is associated with the lone bone fracture
Measured: initially, 6 months, one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
- Sponsor type
- University, hospital or other
- Collaborators
- BG Klinik Murnau, BG Trauma Center Ludwigshafen, BG Klinikum Duisburg, BG Klink Hamburg, Unfallkrankenhaus Berlin, BG Ambulanz Bremen, Bundeswehrkrankenhaus Ulm, Paracelsus Universität Salzburg
- Responsible party
- Sponsor
- Investigators
- Marie K Reumann, MD, Principal investigator, Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758427
- Sponsor's protocol ID
- HELICOPTER
- Acronym
- HELICOPTER
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of all patients will be pseudonymised. No individual participant data will be identified.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation
- ClinicalTrials.gov ID
- NCT06758427
- Acronym / sponsor ID
- HELICOPTER / HELICOPTER
- Conditions
- Postoperative Complications, Surgical Site Infection, Wound Infection, Non-healing Wound, Pseudarthrosis, Bone Infection
- Keywords
- long bone fracture, trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik TuUniversity, hospital or other
- Collaborators
- BG Klinik Murnau, BG Trauma Center Ludwigshafen, BG Klinikum Duisburg, BG Klink Hamburg, Unfallkrankenhaus Berlin, BG Ambulanz Bremen, Bundeswehrkrankenhaus Ulm, Paracelsus Universität Salzburg
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 3 Jan 2025 (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.
At least ten percent of trauma patients suffer from any sort of complication. The study aims to identify a risk factor profile to early identify trauma patients at risk.
Detailed description
Trauma patients suffer from a high risk of complications that ranges from soft tissue complications, surgical site infection till bone non-union. Comorbidities are often know to be associated with complications. Also certain blood markers could be identified to be an indicator.
However, certain risk factors have only been investigated in small trauma cohorts so far. This study is a prospective multi center cohort trail that aims to collect all clinical data, comorbidities, medication, blood markers in trauma patients after long bone fractures. In a 6 months and one year follow up patients with complications will be identified. Methods of machine learning will help to identify a risk factor profile for certain groups of patients with complications.
The aim of the study is to early identify patients at risk for a complication after trauma according to their blood marker, clinical, comorbidity and medication profile.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients that suffer from an acute lone bone fracture, require surgical treatment and belong to the age group of being able to working (18 - 67 years old)
Key inclusion criteria (1 listed)
- acute long bone fracture (humerus, ulna, radius, femur, tibia) with surgical treatment
Key exclusion criteria (4 listed)
- associated severe injury (ISS > 16)
- associated traumatic brain injury
- associated traumatic spine injury
- dementia
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
any complication after long bone fracture
Time frame: 6 months, one year
number of patients that suffer from a complication after surgical treatment of a primary long bone fracture
Clavien Dindo Classification
Time frame: 6 months, one year
Clavien Dindo Classification classifies surgical complications. All patients will be classified according to Clavien Dindo after 6 months and one year.
4 secondary outcomes
Charlson Comorbidity Index (CCI)
Time frame: Initially
number of medications
Time frame: initally
EuroQual 5 Dimensions Questionnaire (EQ5D5L)
Time frame: initially, 6 months, one year.
patient reported outcome measure associated with the lone bone fracture
Time frame: initially, 6 months, one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No. Data of all patients will be pseudonymised. No individual participant data will be identified.
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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.
Marie K Reumann, MD principal investigator
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
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 Postoperative Complications and Surgical Site Infection, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu 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 1 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: opening soon, as of the sponsor's last update on 3 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie K Reumann, MD (+497071606 ext. 3113, mreumann@bgu-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
any complication after long bone fracture (time frame: 6 months, one year). 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 3 Jan 2025.