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

2021년 9월 23일 업데이트: 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.

연구 개요

상태

완전한

정황

정맥혈전색전증

상세 설명

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.

연구 유형

관찰

등록 (실제)

27490

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
The rate of in-hospital VTE 기간: 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 기간: 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 기간: 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 기간: Through discharge, an average of 20 days	The upper normal value 0.55mg/L FEU was used.	Through discharge, an average of 20 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Tsinghua Chang Gung Hospital

수사관

수석 연구원: Weiwei Wu, MD, Beijing Tsinghua Chang Gung Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 6월 1일

기본 완료 (실제)

2020년 4월 30일

연구 완료 (실제)

2020년 4월 30일

연구 등록 날짜

최초 제출

2021년 9월 6일

QC 기준을 충족하는 최초 제출

2021년 9월 23일

처음 게시됨 (실제)

2021년 9월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)