Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism
The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China
1 other identifier
observational
4,000
1 country
1
Brief Summary
The objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with venous thromboembolism (VTE) in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2018
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 29, 2019
November 1, 2019
5.6 years
December 26, 2018
November 26, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Death from all causes
Death from all causes during follow-up
5-year
Death from all causes
Death from all causes during hospitalization
30-day
Secondary Outcomes (2)
Number of Participants with Recurrent VTE
5-year
Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
5-year
Other Outcomes (1)
Number of Participants with Cardiogenic Shock
30-day
Study Arms (2)
Derivation Cohort
Derivation Cohort of Diagnostic Prediction Model: Participants will be recruited from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. The investigators will randomly assign 70% participants to a derivation cohort. Derivation Cohort of Prognostic Prediction Model: Patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018.
Validation Cohort
Validation Cohort of Diagnostic Prediction Model: The investigators plan to randomly assign 30% participants for developing the diagnostic prediction model to a Validation cohort. Validation Cohort of Prognostic Prediction Model: New individuals selected by the same inclusion and exclusion criteria as the derivation cohort of prognostic prediction model from the same institutions as a validation cohort of prognostic prediction model will be recruited from January 2019.
Eligibility Criteria
Development and validation of diagnostic prediction model: Participants will undergo recruitment from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. Development and validation of prognostic prediction model: The investigators will identify patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018 using the Hospital Information Manage System(HIMS) database.
You may qualify if:
- \> 18 years old
- First episode of PE and/or DVT (diagnosed by pulmonary angiogram, chest computed tomography pulmonary angiography(CTPA), Ventilation/Perfusion (V/Q) lung scan read as high probability by the radiologist, and/or (+) bilateral lower limb venous compression ultrasonography (CCUS))
You may not qualify if:
- Patients with prior VTE
- Cannot provide written informed consent
- Unable to read questionnaire in Chinese or English
- a record of pregnancy in the preceding 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ya-Wei Xulead
- Nanfang Hospital, Southern Medical Universitycollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Study Sites (1)
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, 200072, China
Related Publications (1)
Wang F, Wang L, Yan C, Chang X, Wang H, Zhu K, Xu Y, Xu D. Algorithms of Electrocardiographic Changes for Quantitative and Localization Analysis of Thrombus Burden in Patients with Acute Pulmonary Thromboembolism. Rev Cardiovasc Med. 2023 Oct 7;24(10):281. doi: 10.31083/j.rcm2410281. eCollection 2023 Oct.
PMID: 39077587DERIVED
Biospecimen
Peripheral blood collected at various time points according to the study cohort
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dachun Xu, Ph.D
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Cardiology
Study Record Dates
First Submitted
December 26, 2018
First Posted
January 14, 2019
Study Start
June 1, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
November 29, 2019
Record last verified: 2019-11