Trauma (Including Fractures)NCT07204405
Haemorrhage From Severe Neck and Facial Injuries - Characteristics, Management and Outcomes
An observational study of Trauma (Including Fractures) and Facial Bones Fracture, run by Karolinska University Hospital.
Trial summary
This is a descriptive observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data will be collected from the Karolinska Trauma Registry for all patients from 2015 to 2024. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma (Including Fractures), Facial Bones Fracture, Neck Injuries
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2025
- How long will I take part?
- 30 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients included in the Karolinska Trauma Registry. Those with an AIS>2 for neck or facial injury will be studied in more detail.
Who may be able to join
- Patients included in the Karolinska Trauma Registry
Who cannot join
- -
About this study
This is a descriptive observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data will be collected from the Karolinska Trauma Registry for all patients from 2015 to 2024. A more detailed dataset will be extracted from the Trauma Registry for all patients with serious facial or neck injuries. For those patients, data will also manually be extracted from their clinical records.
Read the detailed description
Data will be collected from the Karolinska Trauma Registry for all patients from 2015 to 2024. A more detailed dataset will be extracted from the Trauma Registry for all patients with an Abbreviated Injury Scale (AIS) severity score of ≥ 3 for facial or neck injuries. Data will include demographics, injury mechanism, injury type, physiology, treatment and outcome. For those patients with a severe facial or neck injury, data will also manually be extracted from their clinical records regarding prehospital details, initial physiology, injury type, treatment and bleeding.
- Keywords
- Facial injury, Neck injury, Trauma, Bleeding
- Medical subject headings
- Wounds and Injuries, Neck Injuries, Facial Injuries, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from bleeding
Death from bleeding within 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma (Including Fractures)Studies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Other
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Magnus Hedberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204405
- Sponsor's protocol ID
- K 2025-7172
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemorrhage From Severe Neck and Facial Injuries - Characteristics, Management and Outcomes
- ClinicalTrials.gov ID
- NCT07204405
- Acronym / sponsor ID
- K 2025-7172
- Keywords
- Facial injury, Neck injury, Trauma, Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 2 Oct 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.
This is a descriptive observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data will be collected from the Karolinska Trauma Registry for all patients from 2015 to 2024. A more detailed dataset will be extracted from the Trauma Registry for all patients with serious facial or neck injuries. For those patients, data will also manually be extracted from their clinical records.
Detailed description
Data will be collected from the Karolinska Trauma Registry for all patients from 2015 to 2024. A more detailed dataset will be extracted from the Trauma Registry for all patients with an Abbreviated Injury Scale (AIS) severity score of ≥ 3 for facial or neck injuries. Data will include demographics, injury mechanism, injury type, physiology, treatment and outcome. For those patients with a severe facial or neck injury, data will also manually be extracted from their clinical records regarding prehospital details, initial physiology, injury type, treatment and bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients included in the Karolinska Trauma Registry. Those with an AIS>2 for neck or facial injury will be studied in more detail.
Key inclusion criteria (1 listed)
- Patients included in the Karolinska Trauma Registry
Key exclusion criteria (1 listed)
- -
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
Death from bleeding
Time frame: 30 days
Death from bleeding within 30 days.
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 2 Oct 2025.
- 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 Trauma (Including Fractures) and Facial Bones Fracture, run by Karolinska University Hospital.
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 2 Oct 2025. 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?
Death from bleeding (time frame: 30 days). 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 2 Oct 2025.