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

23 september 2021 bijgewerkt door: Beijing Tsinghua Chang Gung Hospital

Venous Thromboembolism Risk Profiles Among Hospitalized Patients in Chinese General Hospital- a Cross-sectional Single-institution Based Study

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Veneuze trombo-embolie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

27490

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- - Beijing, China, 102218
    - Beijing Tsinghua Chang Gung Hosipital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
The rate of in-hospital VTE Tijdsspanne: 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.	From June 2018 to April 2020
Caprini risk assessment model scores Tijdsspanne: 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).	Through discharge, an average of 20 days
Padua prediction score scores Tijdsspanne: Through discharge, an average of 20 days	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 Tijdsspanne: Through discharge, an average of 20 days	The upper normal value 0.55mg/L FEU was used.	Through discharge, an average of 20 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Onderzoekers

Hoofdonderzoeker: Weiwei Wu, MD, Beijing Tsinghua Chang Gung Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2018

Primaire voltooiing (Werkelijk)

30 april 2020

Studie voltooiing (Werkelijk)

30 april 2020

Studieregistratiedata

Eerst ingediend

6 september 2021

Eerst ingediend dat voldeed aan de QC-criteria

23 september 2021

Eerst geplaatst (Werkelijk)

27 september 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)