Trauma InjuryNCT06475612
Using the GTOS to Stratify the Mortality Risk of Adult Trauma Patients
An observational study of Trauma Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Trauma significantly impacts both short- and long-term health outcomes, resulting in substantial mortality. Early identification and risk stratification in trauma patients are crucial for timely medical interventions. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Death and Survival
- How many people
- 40,068 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 May 2024to 7 Jun 2024
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort included 46,808 trauma patients from the Trauma Registry System, covering the period from 2009 to 2021 Of these, 41,131 were adult patients aged 20 years and older. After excluding patients with burns (n = 1,040), hanging injuries (n = 19), drowning (n = 3), and unavailable laboratory data (n = 1), a final study population of 40,068 patients was analyzed. Within this cohort, there were 818 deaths, and 39,250 patients survived.
Who may be able to join
- The study includes all patients aged equal to or over twenty who had trauma.
Who cannot join
- Patients with burns.
- Patients with hangings.
- Patients with drowning.
- Patients with with unavailable laboratory data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the Geriatric Trauma Outcome Score (GTOS) to Stratify the Mortality Risk of Adult Trauma Patients
Trauma significantly impacts both short- and long-term health outcomes, resulting in substantial mortality. Early identification and risk stratification in trauma patients are crucial for timely medical interventions. The Geriatric Trauma Outcome Score (GTOS), designed by incorporating age, the Injury Severity Score (ISS), and the need for packed red blood cell transfusion, has emerged as a valuable prognostic tool for elderly trauma patients, but its applicability to general trauma patients remains underexplored.
- Conditions
- Trauma Injury
- Being tested
- Death, Survival
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeathOther
Mortality group.
SurvivalOther
Survival group.
| Study group | Role | What they receive |
|---|---|---|
| Trauma Patients | The study cohort included 46,808 trauma patients from the Trauma Registry System, covering the period from 2009 to 2021. Of these, 40,068 were adult patients aged 20 years and older. Receives: Other: Death; Other: Survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality outcome
Mortality outcome of trauma patients.
Measured: Through hospital stay of patients, an average of 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start17 May 2024
- Primary completion3 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475612
- Sponsor's protocol ID
- 202400775B0
- Status last verified
- May 2024
- First submitted
- 21 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Geriatric Trauma Outcome Score (GTOS) to Stratify the Mortality Risk of Adult Trauma Patients
- ClinicalTrials.gov ID
- NCT06475612
- Acronym / sponsor ID
- 202400775B0
- Conditions
- Trauma Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,068 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 26 Jun 2024 (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.
Trauma significantly impacts both short- and long-term health outcomes, resulting in substantial mortality. Early identification and risk stratification in trauma patients are crucial for timely medical interventions. The Geriatric Trauma Outcome Score (GTOS), designed by incorporating age, the Injury Severity Score (ISS), and the need for packed red blood cell transfusion, has emerged as a valuable prognostic tool for elderly trauma patients, but its applicability to general trauma patients remains underexplored.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma Patients | – | Other: Death, Other: SurvivalThe study cohort included 46,808 trauma patients from the Trauma Registry System, covering the period from 2009 to 2021. Of these, 40,068 were adult patients aged 20 years and older. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort included 46,808 trauma patients from the Trauma Registry System, covering the period from 2009 to 2021 Of these, 41,131 were adult patients aged 20 years and older. After excluding patients with burns (n = 1,040), hanging injuries (n = 19), drowning (n = 3), and unavailable laboratory data (n = 1), a final study population of 40,068 patients was analyzed. Within this cohort, there were 818 deaths, and 39,250 patients survived.
Key inclusion criteria (1 listed)
- The study includes all patients aged equal to or over twenty who had trauma.
Key exclusion criteria (4 listed)
- Patients with burns.
- Patients with hangings.
- Patients with drowning.
- Patients with with unavailable laboratory data.
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 |
|---|---|---|
| DeathMortality group. | Other | Trauma Patients |
| SurvivalSurvival group. | Other | Trauma Patients |
Primary outcome
Mortality outcome
Time frame: Through hospital stay of patients, an average of 14 days.
Mortality outcome of trauma patients.
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 26 Jun 2024.
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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.
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 Trauma Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 26 Jun 2024. 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 Taiwan. 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?
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?
Mortality outcome (time frame: Through hospital stay of patients, an average of 14 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 26 Jun 2024.