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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism (VTE)

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Dachun Xu, Ph.D; Phone Number: 0086-18917684045; Email: xdc77@tongji.edu.cn
• Study Contact Backup: Name: Fan Wang, MD; Phone Number: 0086-15216717487; Email: 15216717487@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth people's hospital, Tongji university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)	CTEPH can be diagnosed by an echocardiogram or a CTPA.	5-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ya-Wei Xu
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: Dachun Xu, Ph.D, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 26, 2018
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: DOMESTIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No