Venous ThromboembolismNCT07767279
High-Risk Factors for VTE Death
An observational study of Venous Thromboembolism, run by China International Neuroscience Institution at 1 site in China.
Trial summary
Study population and characteristics This retrospective cohort study initially screened 105,168 consecutive hospitalized patients at Shihezi People's Hospital from February 2022 to June 2025. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- comorbidity, Respiratory Failure and Sepsis
- How many people
- 105,168 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Jun 2025
- 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: This retrospective cohort study initially screened 105,168 consecutive hospitalized patients at Shihezi People's Hospital from February 2022 to June 2025
Who may be able to join
- age ≥ 18 years;
- acute VTE
- complete electronic medical records available
Who cannot join
- missing key records variables (discharge status, follow-up data)
- chronic VTE (symptom duration > 31 days)
- VTE diagnosed at another hospital without confirmatory imaging available.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832099
About this study
Official title: Real-world Evidence of High-risk Mortality Factors in Venous Thromboembolism: a Retrospective Cohort Study
Study population and characteristics This retrospective cohort study initially screened 105,168 consecutive hospitalized patients at Shihezi People's Hospital from February 2022 to June 2025. Acute symptomatic venous thromboembolism (VTE) was defined as newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) by imaging confirmation. Diagnosis was confirmed by at least one of the following objective methods: compression ultrasonography showing non-compressible venous segments for DVT, or computed tomography pulmonary angiography (CTPA) showing intraluminal filling defects for PE. All diagnoses were extracted from the hospital's VTE Dynamic Management Data System.Symptom status was assessed at the time of imaging. The research protocol was approved by the ethics committees. The requirement for written informed consent was waived, as the study used clinical information obtained during routine clinical practice. This study was approved by the Ethics Committee of Shihezi People's Hospital (SHZ-2403).
Inclusion criteria: (1) age ≥ 18 years; (2)acute VTE as defined above; (3) complete electronic medical records available.
Read more
Exclusion criteria: (1) missing key variables (e.g., discharge status, follow-up data, or ≥20% of prespecified risk factors); (2) chronic VTE (symptom duration > 31 days); (3)VTE diagnosed at another hospital without confirmatory imaging available.
Study Design and Grouping Definition The hospitals databases were searched for clinical diagnoses and imaging examinations using the VTE Dynamic Management Data System (VTE Intelligent Diagnosis and Treatment Support System, developed by DrBreath Medical Company, Beijing). Accordingly, all patients diagnosed with VTE were classified into two mutually exclusive groups based on their vital status at the end of follow-up: the Survival Group (patients alive at last contact) and the Death Group (patients who died from any cause during hospitalization or follow-up). This outcome-driven dichotomy was established to compare baseline characteristics, comorbidity profiles, and the distribution of high-risk factors between survivors and non-survivors, thereby enabling the identification of mortality-associated determinants. No additional matching or stratification was applied at this stage.
Endpoints and Clinical Follow-up The primary endpoints. The primary endpoint of this study was the occurrence of all-cause death during the follow-up period. Based on this endpoint, patients were dichotomized into the Survival Group and the Death Group to enable comparative analyses of baseline characteristics, comorbidity profiles, and risk factor distributions. All-cause mortality in VTE patients assessed throughout the entire follow-up period from the date of VTE diagnosis (baseline) until the end of the study period (June 1, 2025).
Secondary endpoints included the following outcomes assessed at prespecified time points: 1) In-hospital mortality: defined as death occurring during the index hospitalization, with the time at risk beginning at the date of hospital admission and ending at the date of hospital discharge or in-hospital death. 2) 30-day mortality: defined as death from any cause occurring within 30 days following the date of VTE diagnosis. 3) 90-day mortality: defined as death from any cause occurring within 90 days following the date of VTE diagnosis. 4) Recurrent VTE: defined as new onset of objectively confirmed deep vein thrombosis or pulmonary embolism following complete symptomatic resolution of the index event. Recurrent VTE was assessed at 30 days, 90 days, and at the end of follow-up. 6) Length of hospital stay: calculated as the total number of days from admission date to discharge date or in-hospital death. All secondary outcomes were independently adjudicated by the clinical event committee. Follow-up time was calculated from the date of VTE diagnosis to the date of death, last contact, or study end (June 1, 2025), with censoring applied for patients lost to follow-up during study. Collection of follow-up information was mainly conducted through review of hospital charts, and additional follow-up information was collected through contact with patients, relatives, and/or referring physicians by phone and/or mail with questions regarding vital status, recurrent VTE, bleeding, invasive procedure, acute myocardial infarction, stroke and status of anticoagulation therapy.
Data Sources and Screening Process for High-Risk Factors All data were sourced from the hospital's electronic medical record system by the VTE Intelligent Decision Support System. For each patient with VTE, general medical history and comorbidities were extracted. Data were automatically checked for missing or contradictory input and values out of the expected range. Additional monitoring for the quality of data was performed at the general office of the registry. Screening Process for High-Risk Factors: Key high-risk factors were initially identified based on the latest
- Conditions
- Venous Thromboembolism
- Being tested
- comorbidity, Respiratory Failure, Sepsis, Hemorrhage, Pulmonary Embolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comorbidityOther
comorbidity
Respiratory FailureOther
Respiratory Failure
SepsisOther
Sepsis
HemorrhageOther
Hemorrhage
Pulmonary EmbolismOther
Pulmonary Embolism
| Study group | Role | What they receive |
|---|---|---|
| 2 | Not described Receives: Other: comorbidity; Other: Respiratory Failure; Other: Sepsis; Other: Hemorrhage; Other: Pulmonary Embolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of all-cause death
Measured: from February 2022 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Feb 2022
- Primary completion1 Jun 2025
- 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 Venous ThromboembolismStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 105,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767279
- Sponsor's protocol ID
- SHZ-2403
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evidence of High-risk Mortality Factors in Venous Thromboembolism: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07767279
- Acronym / sponsor ID
- SHZ-2403
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105,168 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Aug 2026 (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.
Study population and characteristics This retrospective cohort study initially screened 105,168 consecutive hospitalized patients at Shihezi People's Hospital from February 2022 to June 2025. Acute symptomatic venous thromboembolism (VTE) was defined as newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) by imaging confirmation. Diagnosis was confirmed by at least one of the following objective methods: compression ultrasonography showing non-compressible venous segments for DVT, or computed tomography pulmonary angiography (CTPA) showing intraluminal filling defects for PE. All diagnoses were extracted from the hospital's VTE Dynamic Management Data System.Symptom status was assessed at the time of imaging. The research protocol was approved by the ethics committees. The requirement for written informed consent was waived, as the study used clinical information obtained during routine clinical practice. This study was approved by the Ethics Committee of Shihezi People's Hospital (SHZ-2403).
Inclusion criteria: (1) age ≥ 18 years; (2)acute VTE as defined above; (3) complete electronic medical records available.
Exclusion criteria: (1) missing key variables (e.g., discharge status, follow-up data, or ≥20% of prespecified risk factors); (2) chronic VTE (symptom duration > 31 days); (3)VTE diagnosed at another hospital without confirmatory imaging available.
Study Design and Grouping Definition The hospitals databases were searched for clinical diagnoses and imaging examinations using the VTE Dynamic Management Data System (VTE Intelligent Diagnosis and Treatment Support System, developed by DrBreath Medical Company, Beijing). Accordingly, all patients diagnosed with VTE were classified into two mutually exclusive groups based on their vital status at the end of follow-up: the Survival Group (patients alive at last contact) and the Death Group (patients who died from any cause during hospitalization or follow-up). This outcome-driven dichotomy was established to compare baseline characteristics, comorbidity profiles, and the distribution of high-risk factors between survivors and non-survivors, thereby enabling the identification of mortality-associated determinants. No additional matching or stratification was applied at this stage.
Endpoints and Clinical Follow-up The primary endpoints. The primary endpoint of this study was the occurrence of all-cause death during the follow-up period. Based on this endpoint, patients were dichotomized into the Survival Group and the Death Group to enable comparative analyses of baseline characteristics, comorbidity profiles, and risk factor distributions. All-cause mortality in VTE patients assessed throughout the entire follow-up period from the date of VTE diagnosis (baseline) until the end of the study period (June 1, 2025).
Secondary endpoints included the following outcomes assessed at prespecified time points: 1) In-hospital mortality: defined as death occurring during the index hospitalization, with the time at risk beginning at the date of hospital admission and ending at the date of hospital discharge or in-hospital death. 2) 30-day mortality: defined as death from any cause occurring within 30 days following the date of VTE diagnosis. 3) 90-day mortality: defined as death from any cause occurring within 90 days following the date of VTE diagnosis. 4) Recurrent VTE: defined as new onset of objectively confirmed deep vein thrombosis or pulmonary embolism following complete symptomatic resolution of the index event. Recurrent VTE was assessed at 30 days, 90 days, and at the end of follow-up. 6) Length of hospital stay: calculated as the total number of days from admission date to discharge date or in-hospital death. All secondary outcomes were independently adjudicated by the clinical event committee. Follow-up time was calculated from the date of VTE diagnosis to the date of death, last contact, or study end (June 1, 2025), with censoring applied for patients lost to follow-up during study. Collection of follow-up information was mainly conducted through review of hospital charts, and additional follow-up information was collected through contact with patients, relatives, and/or referring physicians by phone and/or mail with questions regarding vital status, recurrent VTE, bleeding, invasive procedure, acute myocardial infarction, stroke and status of anticoagulation therapy.
Data Sources and Screening Process for High-Risk Factors All data were sourced from the hospital's electronic medical record system by the VTE Intelligent Decision Support System. For each patient with VTE, general medical history and comorbidities were extracted. Data were automatically checked for missing or contradictory input and values out of the expected range. Additional monitoring for the quality of data was performed at the general office of the registry. Screening Process for High-Risk Factors: Key high-risk factors were initially identified based on the latest
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Other: comorbidity, Other: Respiratory Failure, Other: Sepsis, Other: Hemorrhage, Other: Pulmonary Embolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study initially screened 105,168 consecutive hospitalized patients at Shihezi People's Hospital from February 2022 to June 2025
Key inclusion criteria (3 listed)
- age ≥ 18 years;
- acute VTE
- complete electronic medical records available
Key exclusion criteria (3 listed)
- missing key records variables (discharge status, follow-up data)
- chronic VTE (symptom duration > 31 days)
- VTE diagnosed at another hospital without confirmatory imaging available.
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 |
|---|---|---|
| comorbiditycomorbidity | Other | 2 |
| Respiratory FailureRespiratory Failure | Other | 2 |
| SepsisSepsis | Other | 2 |
| HemorrhageHemorrhage | Other | 2 |
| Pulmonary EmbolismPulmonary Embolism | Other | 2 |
Primary outcome
the occurrence of all-cause death
Time frame: from February 2022 to June 2025
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 17 Aug 2026.
- 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.
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 Venous Thromboembolism, run by China International Neuroscience Institution 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 3 inclusion and 3 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 17 Aug 2026. 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?
the occurrence of all-cause death (time frame: from February 2022 to June 2025). 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 17 Aug 2026.