Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism

Venous Thromboembolism (VTE) Clinical Trial

Official title:

The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03802929
• Other study ID #: DOMESTIC
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2019
• Source: Shanghai 10th People's Hospital
• Contact: Dachun Xu, Ph.D
• Phone: 0086-18917684045
• Email: xdc77[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the leading causes of mortality that need to be accurately diagnosed and effectively managed. Although a number of clinical decision rules in the domain of VTE have been presented in the literature, such as the well-known prediction models developed by Wells and colleagues, the prognostic models to assess VTE recurrence risk in patients who suffered from a VTE or the Pulmonary Embolism Severity Index (PESI) for short-term mortality risk in PE patients, and various other diagnostic models for both DVT and PE. They are few designed for Chinese patients. The primary objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with VTE in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. > 18 years old

2. 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))

Exclusion Criteria:

1. Patients with prior VTE

2. Cannot provide written informed consent

3. Unable to read questionnaire in Chinese or English

4. a record of pregnancy in the preceding 12 months

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism (VTE)

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital, Tongji University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Ya-Wei Xu	First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Cardiogenic Shock	Cardiogenic shock defined as hemodynamic instability(systolic blood pressure<90 mm Hg, or use of inotropic support)	30-day
Primary	Death from all causes	Death from all causes during follow-up	5-year
Primary	Death from all causes	Death from all causes during hospitalization	30-day
Secondary	Number of Participants with Recurrent VTE	Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.	5-year
Secondary	Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)	CTEPH can be diagnosed by an echocardiogram or a CTPA.	5-year