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Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism

2019年11月26日 更新者：Ya-Wei Xu

The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China

The objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with venous thromboembolism (VTE) in China.

研究概览

地位

招聘中

条件

详细说明

Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the leading causes of mortality that need to be accurately diagnosed and effectively managed. Although a number of clinical decision rules in the domain of VTE have been presented in the literature, such as the well-known prediction models developed by Wells and colleagues, the prognostic models to assess VTE recurrence risk in patients who suffered from a VTE or the Pulmonary Embolism Severity Index (PESI) for short-term mortality risk in PE patients, and various other diagnostic models for both DVT and PE. They are few designed for Chinese patients. The primary objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with VTE in China.

研究类型

观察性的

注册 (预期的)

4000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Shanghai
      • Shanghai、Shanghai、中国、200072
        • 招聘中
        • Shanghai Tenth people's hospital, Tongji university

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Development and validation of diagnostic prediction model:

Participants will undergo recruitment from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019.

Development and validation of prognostic prediction model:

The investigators will identify patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018 using the Hospital Information Manage System(HIMS) database.

描述

Inclusion Criteria:

  1. > 18 years old
  2. First episode of PE and/or DVT (diagnosed by pulmonary angiogram, chest computed tomography pulmonary angiography(CTPA), Ventilation/Perfusion (V/Q) lung scan read as high probability by the radiologist, and/or (+) bilateral lower limb venous compression ultrasonography (CCUS))

Exclusion Criteria:

  1. Patients with prior VTE
  2. Cannot provide written informed consent
  3. Unable to read questionnaire in Chinese or English
  4. a record of pregnancy in the preceding 12 months

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Derivation Cohort

Derivation Cohort of Diagnostic Prediction Model:

Participants will be recruited from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. The investigators will randomly assign 70% participants to a derivation cohort.

Derivation Cohort of Prognostic Prediction Model:

Patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018.
Validation Cohort

Validation Cohort of Diagnostic Prediction Model:

The investigators plan to randomly assign 30% participants for developing the diagnostic prediction model to a Validation cohort.

Validation Cohort of Prognostic Prediction Model:

New individuals selected by the same inclusion and exclusion criteria as the derivation cohort of prognostic prediction model from the same institutions as a validation cohort of prognostic prediction model will be recruited from January 2019.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Death from all causes
大体时间：5-year
Death from all causes during follow-up
5-year
Death from all causes
大体时间：30-day
Death from all causes during hospitalization
30-day

次要结果测量

结果测量
措施说明
大体时间
Number of Participants with Recurrent VTE
大体时间：5-year
Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.
5-year
Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
大体时间：5-year
CTEPH can be diagnosed by an echocardiogram or a CTPA.
5-year

其他结果措施

结果测量
措施说明
大体时间
Number of Participants with Cardiogenic Shock
大体时间：30-day
Cardiogenic shock defined as hemodynamic instability(systolic blood pressure<90 mm Hg, or use of inotropic support）
30-day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ya-Wei Xu

合作者

First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University

调查人员

  • 首席研究员：Dachun Xu, Ph.D、Shanghai 10th People's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年6月1日

初级完成 (预期的)

2024年12月31日

研究完成 (预期的)

2024年12月31日

研究注册日期

首次提交

2018年12月26日

首先提交符合 QC 标准的

2019年1月11日

首次发布 (实际的)

2019年1月14日

研究记录更新

最后更新发布 (实际的)

2019年11月29日

上次提交的符合 QC 标准的更新

2019年11月26日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • DOMESTIC

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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