このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。英語版ソーステキスト用。

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

2021年9月23日更新者：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.

調査の概要

状態

完了

条件

静脈血栓塞栓症

詳細な説明

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.

研究の種類

観察的

入学 (実際)

27490

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

中国
- - Beijing、中国、102218
    - Beijing Tsinghua Chang Gung Hosipital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
The rate of in-hospital VTE 時間枠：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 時間枠：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 時間枠：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 時間枠：Through discharge, an average of 20 days	The upper normal value 0.55mg/L FEU was used.	Through discharge, an average of 20 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Beijing Tsinghua Chang Gung Hospital

捜査官

主任研究者：Weiwei Wu, MD、Beijing Tsinghua Chang Gung Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年6月1日

一次修了 (実際)

2020年4月30日

研究の完了 (実際)

2020年4月30日

試験登録日

最初に提出

2021年9月6日

QC基準を満たした最初の提出物

2021年9月23日

最初の投稿 (実際)

2021年9月27日

学習記録の更新

投稿された最後の更新 (実際)