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

23. september 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Venøs tromboembolisme

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

27490

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
The rate of in-hospital VTE Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: Through discharge, an average of 20 days	The upper normal value 0.55mg/L FEU was used.	Through discharge, an average of 20 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2018

Primær fullføring (Faktiske)

30. april 2020

Studiet fullført (Faktiske)

30. april 2020

Datoer for studieregistrering

Først innsendt

6. september 2021

Først innsendt som oppfylte QC-kriteriene

23. september 2021

Først lagt ut (Faktiske)

27. september 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)