Thorax InjuriesMCTTVTENCT05770232
Retrospectively Analyze the Risk Factors of VTE in 5774 Patients With Thoracic Trauma From 33 Hospitals in China, and Established a Risk Prediction Model
An observational study of Thorax Injuries and Embolism Vein, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial summary
Retrospectively analyze the risk factors of VTE in 5774 patients with thoracic trauma from 33 hospitals in China, and established a risk prediction model Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thorax Injuries, Embolism Vein, Embolism, Pulmonary
- How many people
- 5,774 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 30 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18-80 years of age who were admitted within 3 days of chest trauma, did not have VTE prior to admission and were not receiving prophylactic anticoagulation. The chest trauma AIS score of QI patients with multiple injuries was greater than or equal to 3, and the chest trauma score of other combined injuries was less than or equal to 2.
Who may be able to join
- admitted within three days of the chest trauma, VTE has not yet occurred, AIS score of thoracic injury was greater than or equal to 3, AIS score of other combined injuries was less than or equal to 2.
Who cannot join
- received preventive physical or chemical anticoagulation before admission, VTE occurred before admission
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: In Order to Explore the Risk Factors of VTE After Acute Thoracic Trauma, we Collected the Diagnosis and Treatment Information of 5774 Patients With Thoracic Trauma From 33 Hospitals in China, Retrospectively Analyzed the Risk Factors of VTE in Patients With Thoracic Trauma, and Established a Risk Prediction Model.
Retrospectively analyze the risk factors of VTE in 5774 patients with thoracic trauma from 33 hospitals in China, and established a risk prediction model
Read the detailed description
In order to explore the risk factors of VTE after acute thoracic trauma, we collected the diagnosis and treatment information of 5774 patients with thoracic trauma from 33 hospitals in China, retrospectively analyzed the risk factors of VTE in patients with thoracic trauma, and established a risk prediction model.
- Conditions
- Thorax Injuries, Embolism Vein, Embolism, Pulmonary, Rib Fractures
- Keywords
- venous thrombus embolism, Thorax Injuries, risk factors, prediction model
- Medical subject headings
- Thoracic Injuries, Pulmonary Embolism, Rib Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE
venous thrombus embolism, including pulmonary embolism and deep vein thrombosis
Measured: Peri-treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Sep 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thorax InjuriesStudies 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
- Retrospective
- Enrolment
- 5,774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weigang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770232
- Sponsor's protocol ID
- multi-center thorax VTE
- Acronym
- MCTTVTE
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Order to Explore the Risk Factors of VTE After Acute Thoracic Trauma, we Collected the Diagnosis and Treatment Information of 5774 Patients With Thoracic Trauma From 33 Hospitals in China, Retrospectively Analyzed the Risk Factors of VTE in Patients With Thoracic Trauma, and Established a Risk Prediction Model.
- ClinicalTrials.gov ID
- NCT05770232
- Acronym / sponsor ID
- MCTTVTE / multi-center thorax VTE
- Conditions
- Thorax Injuries, Embolism Vein, Embolism, Pulmonary, Rib Fractures
- Keywords
- venous thrombus embolism, Thorax Injuries, risk factors, prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,774 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Mar 2023 (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.
Retrospectively analyze the risk factors of VTE in 5774 patients with thoracic trauma from 33 hospitals in China, and established a risk prediction model
Detailed description
In order to explore the risk factors of VTE after acute thoracic trauma, we collected the diagnosis and treatment information of 5774 patients with thoracic trauma from 33 hospitals in China, retrospectively analyzed the risk factors of VTE in patients with thoracic trauma, and established a risk prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18-80 years of age who were admitted within 3 days of chest trauma, did not have VTE prior to admission and were not receiving prophylactic anticoagulation. The chest trauma AIS score of QI patients with multiple injuries was greater than or equal to 3, and the chest trauma score of other combined injuries was less than or equal to 2.
Key inclusion criteria (1 listed)
- admitted within three days of the chest trauma, VTE has not yet occurred, AIS score of thoracic injury was greater than or equal to 3, AIS score of other combined injuries was less than or equal to 2.
Key exclusion criteria (1 listed)
- received preventive physical or chemical anticoagulation before admission, VTE occurred before admission
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
VTE
Time frame: Peri-treatment period
venous thrombus embolism, including pulmonary embolism and deep vein thrombosis
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 15 Mar 2023.
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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 Thorax Injuries and Embolism Vein, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
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 15 Mar 2023. 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 China. 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?
VTE (time frame: Peri-treatment period). 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 15 Mar 2023.