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

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ClinicalTrials.gov Identifier: NCT05058521
Recruitment Status : Completed
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Beijing Tsinghua Chang Gung Hospital

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.

Condition or disease
Venous Thromboembolism

Detailed Description:

In this study, the investigators recruited adult inpatients attending Tsinghua Chang Gung Hospital in Beijing from June 2018 to April 2020, screened for patients with a hospital stay over 3 days and new-onset of VTE during hospital stay, and identified the in-hospital VTE patients after excluding patients who presented for DVT and/or PE. Similarly, negative patients were selected by not having a VTE during hospital stay. 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. Data was collected from the TEACH database of Beijing Tsinghua Chang Gung Hospital affiliated with Tsinghua University.

Patients baseline characteristics were extracted from database. VTE risk assessment was conducted with either Caprini risk assessment model (surgical patients) or Padua prediction score (medical patients). The evaluation was started upon admission and regularly repeated depending on the patient's condition. The last evaluation was conducted before discharge. The D-dimer values during hospitalization were also collected.

The rate of in-hospital VTE, distributions of in-hospital VTE patients and the receiver operating characteristic curves were analyzed.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 27490 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 23 Months
Official Title: Venous Thromboembolism Risk Profiles Among Hospitalized Patients in Chinese General Hospital- a Cross-sectional Single-institution Based Study
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. The rate of in-hospital VTE [ Time Frame: From June 2018 to April 2020 ]
    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.

  2. Caprini risk assessment model scores [ Time Frame: Through discharge, an average of 20 days ]
    Patients were stratified of VTE risk as very low risk (0), low risk (1-2), medium risk (3-4), high risk (5 and over).

  3. Padua prediction score scores [ Time Frame: Through discharge, an average of 20 days ]
    Patients were stratified of VTE risk as low risk (0-3) and high risk (4 and over).

  4. D-dimer values [ Time Frame: Through discharge, an average of 20 days ]
    The upper normal value 0.55mg/L FEU was used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators recruited adult inpatients attending Tsinghua Chang Gung Hospital in Beijing from June 2018 to April 2020.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who presented for DVT and/or PE
  2. Patients who were admitted in emergency department

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058521


Locations
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China
Beijing Tsinghua Chang Gung Hosipital
Beijing, China, 102218
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
Investigators
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Principal Investigator: Weiwei Wu, MD Beijing Tsinghua Chang Gung Hospital
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Responsible Party: Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT05058521    
Other Study ID Numbers: 19242-4-01
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tsinghua Chang Gung Hospital:
VTE
China
Caprini risk assessment model
Padua prediction score
Risk profiles
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases