- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058521
Venous thromboEmbolism Risk Profiles in Chinese hoSpitalized patiEnts (VERSE Study)
Venous Thromboembolism Risk Profiles Among Hospitalized Patients in Chinese General Hospital- a Cross-sectional Single-institution Based Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China, 102218
- Beijing Tsinghua Chang Gung Hosipital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who presented for DVT and/or PE
- Patients who were admitted in emergency department
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of in-hospital VTE
Time Frame: From June 2018 to April 2020
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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.
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From June 2018 to April 2020
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Caprini risk assessment model scores
Time Frame: Through discharge, an average of 20 days
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Patients were stratified of VTE risk as very low risk (0), low risk (1-2), medium risk (3-4), high risk (5 and over).
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Through discharge, an average of 20 days
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Padua prediction score scores
Time Frame: Through discharge, an average of 20 days
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Patients were stratified of VTE risk as low risk (0-3) and high risk (4 and over).
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Through discharge, an average of 20 days
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D-dimer values
Time Frame: Through discharge, an average of 20 days
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The upper normal value 0.55mg/L FEU was used.
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Through discharge, an average of 20 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Weiwei Wu, MD, Beijing Tsinghua Chang Gung Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19242-4-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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