Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; AnticoagulantsNCT05464901
VTE and the Related Factors Associated With Higher Rates of PE After a DVT in Southwestern China
An observational study of Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Anticoagulants, run by Wei Huang.
Trial summary
Little is known about the current management status of venous thromboembolism (VTE) in Southwestern China. We aimed to investigate the status of anticoagulant administration in VTE in Southwestern China and assess the potential predictors of deep vein thrombosis (DVT) complicated pulmonary embolism (PE). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Anticoagulants
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2006to 1 Nov 2018
- 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
- Child, Adult, Older adult
Study population: In the patients' characteristics, the hypertensive disorders of pregnancy were defined and classified into (a) hypertension known before pregnancy or present in the first 20 weeks and (b) hypertension arising de novo at or after 20 weeks on the basis of the International Society for the Study of Hypertension in Pregnancy Classification, Diagnosis, and Management Recommendations for International Practice
Who may be able to join
- In the Chinese VTE guidelines, the diagnosis of VTE depends on a series of tests. D-dimer was used to screen for thrombosis, and limb venous ultrasound was used to diagnose DVT. CT pulmonary angiography (CTPA) or pulmonary ventilation perfusion scan was used for the diagnosis of pulmonary embolism. Through the retrieval of patient diagnosis in the database, we retrieved the basic data of all patients diagnosed as VTE during the study period.
Who cannot join
- -
About this study
Official title: The Real-World Treatment Status of Venous Thromboembolism and the Related Factors Associated With Higher Rates of PE After a DVT in Southwestern China
Little is known about the current management status of venous thromboembolism (VTE) in Southwestern China. We aimed to investigate the status of anticoagulant administration in VTE in Southwestern China and assess the potential predictors of deep vein thrombosis (DVT) complicated pulmonary embolism (PE). We extracted data from YiduCloud database from December 2006 to November 2018 and performed a cross-sectional survey of VTE. The demographics, laboratory tests, and anticoagulants were collected and analyzed in the logistic regression model, classification tree and Random Forest model.
Read the detailed description
We established a collaborative epidemiological work of southwestern China for our cross-sectional survey sample, which included hospitalized patients in the seven main medical centers who met the inclusion criteria. The Human Research Committee of Chongqing Medical University approved this study and waived the need for informed consent. Patients were eligible to be included in the study if they are admitted or discharged with a diagnosis of DVT or/and PE and if they ever received treatment in the seven medical centers between December 2006 to November 2018.
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
The maternal cardiac events and the neonatal complications
Primary outcomes of interest were major adverse cardiac events (MACEs), obstetric complications and neonatal adverse clinical events (NACEs).
Measured: 2010-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Dec 2006
- Primary completion1 Jul 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; AnticoagulantsStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Huang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464901
- Sponsor's protocol ID
- 2019XMSB0005627
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real-World Treatment Status of Venous Thromboembolism and the Related Factors Associated With Higher Rates of PE After a DVT in Southwestern China
- ClinicalTrials.gov ID
- NCT05464901
- Acronym / sponsor ID
- 2019XMSB0005627
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Wei HuangUniversity, hospital or other
- Study start
- 1 Dec 2006 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 19 Jul 2022 (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.
Little is known about the current management status of venous thromboembolism (VTE) in Southwestern China. We aimed to investigate the status of anticoagulant administration in VTE in Southwestern China and assess the potential predictors of deep vein thrombosis (DVT) complicated pulmonary embolism (PE). We extracted data from YiduCloud database from December 2006 to November 2018 and performed a cross-sectional survey of VTE. The demographics, laboratory tests, and anticoagulants were collected and analyzed in the logistic regression model, classification tree and Random Forest model.
Detailed description
We established a collaborative epidemiological work of southwestern China for our cross-sectional survey sample, which included hospitalized patients in the seven main medical centers who met the inclusion criteria. The Human Research Committee of Chongqing Medical University approved this study and waived the need for informed consent. Patients were eligible to be included in the study if they are admitted or discharged with a diagnosis of DVT or/and PE and if they ever received treatment in the seven medical centers between December 2006 to November 2018.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- In the patients' characteristics, the hypertensive disorders of pregnancy were defined and classified into (a) hypertension known before pregnancy or present in the first 20 weeks and (b) hypertension arising de novo at or after 20 weeks on the basis of the International Society for the Study of Hypertension in Pregnancy Classification, Diagnosis, and Management Recommendations for International Practice
Key inclusion criteria (1 listed)
- In the Chinese VTE guidelines, the diagnosis of VTE depends on a series of tests. D-dimer was used to screen for thrombosis, and limb venous ultrasound was used to diagnose DVT. CT pulmonary angiography (CTPA) or pulmonary ventilation perfusion scan was used for the diagnosis of pulmonary embolism. Through the retrieval of patient diagnosis in the database, we retrieved the basic data of all patients diagnosed as VTE during the study period.
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
The maternal cardiac events and the neonatal complications
Time frame: 2010-2019
Primary outcomes of interest were major adverse cardiac events (MACEs), obstetric complications and neonatal adverse clinical events (NACEs).
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 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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 Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Anticoagulants, run by Wei Huang.
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 19 Jul 2022. 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?
The maternal cardiac events and the neonatal complications (time frame: 2010-2019). 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 19 Jul 2022.