Venous thromboEmbolism Risk Profiles in Chinese hoSpitalized patiEnts (VERSE Study)

NCT05058521 | Completed

• 1 other identifier: 19242-4-01
• Study Type: observational
• Target: 27,490
• Locations: 1 country
• Sites: 1

Brief Summary

Venous thromboembolism (VTE) is a complex multifactorial disease, mainly manifested by deep vein thrombosis (DVT) and pulmonary embolism (PE). VTE events increase the length of hospitalization and treatment costs and seriously affect the quality of life of patients, so it is increasingly appreciated to identify high-risk patients with VTE and take preventive measures. The Padua prediction score (PPS) and Caprini risk assessment model (RAM) are widely used in clinical practice as common risk assessment scales in medical and surgical departments, respectively. And D-dimer levels have been considered as a well indicator to rule out acute VTE. Previous epidemiological studies on VTE have found the risk of VTE is significantly higher in hospitalized patients than in the general population and the prophylaxis decisions vary among countries, hospitals and departments, indicating current in-hospital VTE prevention strategies are far from optimal and it's imperative to regionalized control of VTE. Therefore, a single-institution-based risk profile study of in-hospital VTE patients is designed to explore current situation of VTE occurrence and predictive efficacy of widely used risk assessment models as well as D-dimer in one of the general hospitals in Beijing, China.

Conditions

Venous Thromboembolism

Keywords

VTE; China; Caprini risk assessment model; Padua prediction score; Risk profiles

Outcome Measures

Primary Outcomes (4)

• The rate of in-hospital VTE

  The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE.

  From June 2018 to April 2020

• Caprini risk assessment model scores

  Patients were stratified of VTE risk as very low risk (0), low risk (1-2), medium risk (3-4), high risk (5 and over).

  Through discharge, an average of 20 days

• Padua prediction score scores

  Patients were stratified of VTE risk as low risk (0-3) and high risk (4 and over).

  Through discharge, an average of 20 days

• D-dimer values

  The upper normal value 0.55mg/L FEU was used.

  Through discharge, an average of 20 days

Study Arms (2)

In-hospital VTE group

In-hospital VTE group includes patients who were with a hospital stay over 3 days and new-onset of VTE during their stay. Patients who presented for VTE were excluded.

Negative group

Negative group includes patients who were with a hospital stay over 3 days and did not have a VTE during their hospital stay.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators recruited adult inpatients attending Tsinghua Chang Gung Hospital in Beijing from June 2018 to April 2020.

You may qualify if:

• Age 18 and over, male or female
• Inpatients with a hospital stay over 3 days
• With or without new-onset of VTE during their stay

You may not qualify if:

• Patients who presented for DVT and/or PE
• Patients who were admitted in emergency department

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hosipital

Beijing, 102218, China

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Weiwei Wu, MD

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 23 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 27, 2021
• Study Start: June 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

CN (1)