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

23 september 2021 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

27490

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Weiwei Wu, MD, Beijing Tsinghua Chang Gung Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2018

Primärt slutförande (Faktisk)

30 april 2020

Avslutad studie (Faktisk)

30 april 2020

Studieregistreringsdatum

Först inskickad

6 september 2021

Först inskickad som uppfyllde QC-kriterierna

23 september 2021

Första postat (Faktisk)

27 september 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 september 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2021

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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