Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism
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|ClinicalTrials.gov Identifier: NCT03802929|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : November 29, 2019
|Condition or disease|
|Venous Thromboembolism (VTE)|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Official Title:||The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
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 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.
- Death from all causes [ Time Frame: 5-year ]Death from all causes during follow-up
- Death from all causes [ Time Frame: 30-day ]Death from all causes during hospitalization
- Number of Participants with Recurrent VTE [ Time Frame: 5-year ]Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.
- Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH) [ Time Frame: 5-year ]CTEPH can be diagnosed by an echocardiogram or a CTPA.
- Number of Participants with Cardiogenic Shock [ Time Frame: 30-day ]Cardiogenic shock defined as hemodynamic instability(systolic blood pressure<90 mm Hg, or use of inotropic support）
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802929
|Contact: Dachun Xu, Ph.Dfirstname.lastname@example.org|
|Contact: Fan Wang, MDemail@example.com|
|Principal Investigator:||Dachun Xu, Ph.D||Shanghai 10th People's Hospital|