住院患者静脉血栓栓塞症特点分析及预测模型构建

注册号:

Registration number:

ChiCTR2600127038 

最近更新日期:

Date of Last Refreshed on:

2026-06-23 14:28:59 

注册时间:

Date of Registration:

2026-06-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

住院患者静脉血栓栓塞症特点分析及预测模型构建

Public title:

Characteristics Analysis and Construction of Predictive Model for Venous Thromboembolism in Inpatients

注册题目简写:

English Acronym:

研究课题的正式科学名称:

住院患者静脉血栓栓塞症特点分析及预测模型构建

Scientific title:

Characteristics Analysis and Construction of Predictive Model for Venous Thromboembolism in Inpatients

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

张烨 

研究负责人:

张烨 

Applicant:

Ye Zhang 

Study leader:

Ye Zhang 

申请注册联系人电话:

Applicant telephone:

+86 7551234567

研究负责人电话:

Study leader's
telephone:

+86 7551234567

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

zhangyezy1986@163.com

研究负责人电子邮件:

Study leader's E-mail:

zhangyezy1986@163.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

浙江省嘉兴市南湖区中环南路1882号

研究负责人通讯地址:

浙江省嘉兴市南湖区中环南路1882号

Applicant address:

1882 Zhonghuan South Road, Nanhu District, Jiaxing City, Zhejiang Province

Study leader's address:

1882 Zhonghuan South Road, Nanhu District, Jiaxing City, Zhejiang Province

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

嘉兴市第一医院

Applicant's institution:

The First Hospital of Jiaxing

研究负责人所在单位:

嘉兴市第一医院

Affiliation of the Leader:

The First Hospital of Jiaxing

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2026-LP-325

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

嘉兴市第一医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of the First Hospital of Jiaxing

伦理委员会批准日期:

Date of approved by ethic committee:

2026-05-11 00:00:00

伦理委员会联系人:

许文

Contact Name of the ethic committee:

Wen Xu

伦理委员会联系地址:

浙江省嘉兴市南湖区中环南路1882号

Contact Address of the ethic committee:

1882 Zhonghuan South Road, Nanhu District, Jiaxing City, Zhejiang Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 573 89976378

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xwkikimi@163.com

研究实施负责(组长)单位:

嘉兴市第一医院

Primary sponsor:

The First Hospital of Jiaxing

研究实施负责(组长)单位地址:

浙江省嘉兴市南湖区中环南路1882号

Primary sponsor's address:

1882 Zhonghuan South Road, Nanhu District, Jiaxing City, Zhejiang Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

嘉兴市第一医院

具体地址:

浙江省嘉兴市南湖区中环南路1882号

Institution
hospital:

The First Hospital of Jiaxing

Address:

1882 Zhonghuan South Road, Nanhu District, Jiaxing City, Zhejiang Province

经费或物资来源:

肺癌精准治疗重点实验室

Source(s) of funding:

Key Laboratory of Precision Therapy for Lung Cancer

研究疾病:

静脉血栓栓塞症  

Target disease:

Venous thromboembolism, VTE

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

研究住院VTE患者的特征,评价现有筛查、评估及预防措施的及时性与有效性,为优化VTE早诊早治防控策略、改善患者预后提供依据。  

Objectives of Study:

To investigate the clinical characteristics of hospitalized patients with venous thromboembolism (VTE), evaluate the timeliness and effectiveness of current VTE screening, risk assessment and preventive measures, and provide evidence for optimizing early diagnosis, early treatment and prevention strategies as well as improving clinical prognoses of these patients.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.患者住院时间≤48小时;
2.疑似VTE诊断,浅静脉血栓;
3.研究期限内非首次确诊的病例。对于多次住院病例,仅纳入首次住院;

Exclusion criteria:

1.Hospital length of stay <= 48 hours; 2.Suspected VTE diagnosis or superficial venous thrombosis; 3.Cases with repeated VTE diagnosis within the research period. For patients with multiple hospital admissions, only the initial hospitalization was enrolled.

研究实施时间:

Study execute time:

From 2026-07-03 00:00:00 To 2029-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-07-03 00:00:00 To 2027-06-30 00:00:00

干预措施:

Interventions:

组别:

VTE患者数据组

样本量:

5800

Group:

Data of VTE patients group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

嘉兴市第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Jiaxing

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

院内全因死亡率

指标类型:

次要指标

Outcome:

In-hospital all-cause mortality

Type:

Secondary indicator

测量时间点:

入院后死亡时间

测量方法:

Measure time point of outcome:

Time from admission to death

Measure method:

指标中文名:

入院48小时后诊断 VTE

指标类型:

主要指标

Outcome:

VTE diagnosed >48 hours after admission

Type:

Primary indicator

测量时间点:

入院后行确诊VTE相关检查

测量方法:

Measure time point of outcome:

Receipt of confirmatory examinations for VTE after admission

Measure method:

指标中文名:

ICU入住率

指标类型:

次要指标

Outcome:

ICU admission rate

Type:

Secondary indicator

测量时间点:

入住ICU或入院后转入ICU

测量方法:

Measure time point of outcome:

Admission to ICU or ICU transfer after hospitalization

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

None

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

None

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

None

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-06-23 14:28:43