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Observational study of VTE in Inpatients
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注册号:

Registration number:

ChiCTR2100047692 

最近更新日期:

Date of Last Refreshed on:

2021-06-22 

注册时间:

Date of Registration:

2021-06-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

住院患者VTE防治观察性研究 

Public title:

Observational study of VTE 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VTE防治观察性研究 

Scientific title:

Observational study of VTE 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:

刘广钦 

研究负责人:

陆清声 

Applicant:

Liu Guangqin 

Study leader:

Lu Qingsheng 

申请注册联系人电话:

Applicant telephone:

+86 13585674307 

研究负责人电话:

Study leader's telephone:

+86 13917292504 

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:

xxliuyedao@163.com 

研究负责人电子邮件:

Study leader's E-mail:

luqs@xueguan.net 

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:

上海市杨浦区长海路168号 

研究负责人通讯地址:

上海市杨浦区长海路168号 

Applicant address:

168 Changhai Road, Yangpu District, Shanghai, China 

Study leader's address:

168 Changhai Road, Yangpu District, Shanghai, China 

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:

200433 

申请人所在单位:

海军军医大学长海医院血管外科 

Applicant's institution:

Vascular Surgery Department of Changhai Hospital,Naval Military Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

CHEC2021-001 

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:

上海长海医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of Changhai Hospital,Shanghai 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-01-08 

伦理委员会联系人:

计一平 

Contact Name of the ethic committee:

Ji Yiping 

伦理委员会联系地址:

上海市杨浦区长海路168号17号楼202室 

Contact Address of the ethic committee:

Room202,Building 17th, 168 Changhai Road, Yangpu District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

海军军医大学长海医院 

Primary sponsor:

Changhai Hospital, Naval Military Medical University 

研究实施负责(组长)单位地址:

上海市杨浦区长海路168号 

Primary sponsor's address:

168 Changhai Road, Yangpu District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

海军军医大学附属长海医院

具体地址:

上海市杨浦区长海路168号

Institution
hospital:

Changhai Hospital, Naval Military Medical University

Address:

168 Changhai Road, Yangpu District

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

静脉血栓栓塞症 

Target disease:

Vevenous thromboembolism 

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 

研究目的:

明确国内住院患者VTE的预防和治疗现状。 

Objectives of Study:

Clarifying the prevention and status of VTE for inpatients in China 

药物成份或治疗方案详述:

本项研究是一项观察性研究,研究者不干涉医生的临床决策和治疗过程,也不增加患者术后的随访工作。仅对患者的临床数据进行有针对性的收集,在住院患者发生VTE后的出院前、1个月、3个月和6个月行常规随访。 本研究预计共有100家左右的中心参与本研究。每中心入组时间12个月,预计每个中心入组患者不设置最低人数。 

Description for medicine or protocol of treatment in detail:

This is an observational studay, Researchers do not interfere in a physicians clinical decision-making and treatmene process,Just a targeted collection of the paitients clinical data.Routine follow-up patients before and 1 month,3 months,and 6 months after discharge. 100 cebters participated in this studay.Acquisition time per center is 12 months,Minimum number of people is not set per center. 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1)入院诊断不包括VTE 2) 院内发生VTE 

Inclusion criteria

1) Admisssion diagnosis does not include VTE; 2) VTE occurred during the hospitalization. 

排除标准:

住院前发生VTE 

Exclusion criteria:

VTE occurred before the hospitalization 

研究实施时间:

Study execute time:

From2021-01-01To 2022-06-30 

征募观察对象时间:

Recruiting time:

From2021-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

1000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

预防和治疗现状

指标类型:

主要指标 

Outcome:

prevention and status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 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):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

多中心整体研究,数据按需求发送给各参与中心

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

Multi-center holistic Studay,Data is sent to each center as required

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:

CRF:Excel文件 EDC:Excel文件

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

CRF:Excel EDC:Excel

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2021-06-22
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