Severe TraumaNCT04934878
Regional Treatment Flow and Prognosis ofTraumatic Thoracic Aortic Injuries：A Multi-center Retrospective Analysis in Zhejiang Province During 11 Years
An observational study of Severe Trauma and Blunt Thoracic Aortic Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Using keywords (main) artery dissection aneurysm (main) artery haematoma (main) To diagnose X-ray imaging reports and medical record home page is a search, check the unit 11 hospitals in Zhejiang Province during the year aortic injury clinical data of 11 years, through the electronic questionnaire to fill in the form… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Trauma, Blunt Thoracic Aortic Injury, Interventional Therapy
- What is being tested?
- Referral information
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2020to 1 Mar 2021
- How long will I take part?
- 1 Day
- 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: Trauma patients
Who may be able to join
- Diagnosis of trauma patients with aortic dissection (aortic aneurysm) (aortic hematoma)
Who cannot join
- Patients with primary aortic dissection, limb pseudoaneurysm, non-aortic associated hematoma, etc.Incomplete or lost data, patients refused
Trial locations and contacts
1 site in 1 country.
About this study
Using keywords (main) artery dissection aneurysm (main) artery haematoma (main) To diagnose X-ray imaging reports and medical record home page is a search, check the unit 11 hospitals in Zhejiang Province during the year aortic injury clinical data of 11 years, through the electronic questionnaire to fill in the form of information, information of diagnosis and treatment of the basic information for the patient injury mechanism and so on carries on the statistical analysis. Basic information includes gender, age, history of hypertension. Injury information includes injury mechanism information and trauma information. Injury mechanism refers to injuries caused by car accidents, high falls and other causes. Injury information includes diagnosis, injury severity score, Glasgow coma index, and Stanford classification of aortic injury. The information of diagnosis and treatment includes the method of treatment, the reason for referral, the time of definitive treatment and the prognosis. The method of treatment is divided into the first treatment group and the referral group. The first treatment group refers to the patients admitted by the hospital for the first time, and the referral group refers to the patients transferred from other hospitals. The reasons for referral include: the suggestion of the hospital after comprehensive consideration, the lack of diagnosis and treatment qualification of the hospital, the subjective will of the patient's family members. Deterministic treatment time refers to the time from injury to imaging examination and the time from injury to surgery and other data to be statistically analyzed.
- Being tested
- Referral information
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral informationBiological
first visit to our hospital/transfer from another hospital
| Study group | Role | What they receive |
|---|---|---|
| Referral information | first visit to our hospital/transfer from another hospital Receives: Biological: Referral information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Treatment Flow And Prognosis of Traumatic Thoracic Aortic Injuries：A Multi-Center Retrospective Analysis in Zhejiang Province During 11 Years
Numbers of hospitals of different levels
Measured: From January 2010 to October 2020,
Regional Treatment Flow And Prognosis of Traumatic Thoracic Aortic Injuries：A Multi-Center Retrospective Analysis in Zhejiang Province During 11 Years
Number of Stanford type(A and B)
Measured: From January 2010 to October 2020,
Regional Treatment Flow And Prognosis of Traumatic Thoracic Aortic Injuries：A Multi-Center Retrospective Analysis in Zhejiang Province During 11 Years
survial rate
Measured: From January 2010 to October 2020,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start19 Dec 2020
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe TraumaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Other
- Time perspective
- Other
- Enrolment
- 234 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hwa Mei Hospital, University of Chinese Academy of Sciences, Zhoushan Hospital Zhejiang Province, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Quzhou People's Hospital Zhejiang Province, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Shaoxing People's Hospital, Ningbo No. 1 Hospital, The Central Hospital of Lishui City, Ningbo Medical Center Lihuili Hospital, Lishui People's Medical, Jinhua Central Hospital, 903 Hospital of Chinese People's Liberation Army, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, First People's Hospital of Hangzhou, Zhejiang Quhua Hospital, Yinzhou Second Hospital, Tiantai County People's Hospital, Taizhou Hospital, The First People's Hospital of Huzhou, Suichang County People's Hospital, Quzhou Second People's Hospital, Ningbo Fenghua District People's Hospital, Jiangshan People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934878
- Sponsor's protocol ID
- 2020-859
- Status last verified
- May 2021
- First submitted
- 5 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Treatment Flow and Prognosis ofTraumatic Thoracic Aortic Injuries：A Multi-center Retrospective Analysis in Zhejiang Province During 11 Years
- ClinicalTrials.gov ID
- NCT04934878
- Acronym / sponsor ID
- 2020-859
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hwa Mei Hospital, University of Chinese Academy of Sciences, Zhoushan Hospital Zhejiang Province, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Quzhou People's Hospital Zhejiang Province, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Shaoxing People's Hospital, Ningbo No. 1 Hospital, The Central Hospital of Lishui City, Ningbo Medical Center Lihuili Hospital, Lishui People's Medical, Jinhua Central Hospital, 903 Hospital of Chinese People's Liberation Army, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, First People's Hospital of Hangzhou, Zhejiang Quhua Hospital, Yinzhou Second Hospital, Tiantai County People's Hospital, Taizhou Hospital, The First People's Hospital of Huzhou, Suichang County People's Hospital, Quzhou Second People's Hospital, Ningbo Fenghua District People's Hospital, Jiangshan People's Hospital
- Study start
- 19 Dec 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Jun 2021 (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.
Using keywords (main) artery dissection aneurysm (main) artery haematoma (main) To diagnose X-ray imaging reports and medical record home page is a search, check the unit 11 hospitals in Zhejiang Province during the year aortic injury clinical data of 11 years, through the electronic questionnaire to fill in the form of information, information of diagnosis and treatment of the basic information for the patient injury mechanism and so on carries on the statistical analysis. Basic information includes gender, age, history of hypertension. Injury information includes injury mechanism information and trauma information. Injury mechanism refers to injuries caused by car accidents, high falls and other causes. Injury information includes diagnosis, injury severity score, Glasgow coma index, and Stanford classification of aortic injury. The information of diagnosis and treatment includes the method of treatment, the reason for referral, the time of definitive treatment and the prognosis. The method of treatment is divided into the first treatment group and the referral group. The first treatment group refers to the patients admitted by the hospital for the first time, and the referral group refers to the patients transferred from other hospitals. The reasons for referral include: the suggestion of the hospital after comprehensive consideration, the lack of diagnosis and treatment qualification of the hospital, the subjective will of the patient's family members. Deterministic treatment time refers to the time from injury to imaging examination and the time from injury to surgery and other data to be statistically analyzed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Referral information | – | Biological: Referral informationfirst visit to our hospital/transfer from another hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients
Key inclusion criteria (1 listed)
- Diagnosis of trauma patients with aortic dissection (aortic aneurysm) (aortic hematoma)
Key exclusion criteria (1 listed)
- Patients with primary aortic dissection, limb pseudoaneurysm, non-aortic associated hematoma, etc.Incomplete or lost data, patients refused
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 |
|---|---|---|
| Referral informationfirst visit to our hospital/transfer from another hospital | Biological | Referral information |
Primary outcome
Regional Treatment Flow And Prognosis of Traumatic Thoracic Aortic Injuries：A Multi-Center Retrospective Analysis in Zhejiang Province During 11 Years
Time frame: From January 2010 to October 2020,
Numbers of hospitals of different levels
Regional Treatment Flow And Prognosis of Traumatic Thoracic Aortic Injuries：A Multi-Center Retrospective Analysis in Zhejiang Province During 11 Years
Time frame: From January 2010 to October 2020,
Number of Stanford type(A and B)
Regional Treatment Flow And Prognosis of Traumatic Thoracic Aortic Injuries：A Multi-Center Retrospective Analysis in Zhejiang Province During 11 Years
Time frame: From January 2010 to October 2020,
survial rate
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 Jul 2021.
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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 Severe Trauma and Blunt Thoracic Aortic Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 Jul 2021. 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?
Regional Treatment Flow And Prognosis of Traumatic Thoracic Aortic Injuries：A Multi-Center Retrospective Analysis in Zhejiang Province During 11 Years (time frame: From January 2010 to October 2020,). The study lists 3 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 15 Jul 2021.