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The prevention and treatment of deep venous thrombosis in ICU patients of Zhejiang Province: Multicenter, prospective, observational research
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注册号:

Registration number:

ChiCTR1900024956 

最近更新日期:

Date of Last Refreshed on:

2019-08-05 

注册时间:

Date of Registration:

2019-08-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

浙江省ICU患者深静脉血栓防治的现状研究 

Public title:

The prevention and treatment of deep venous thrombosis in ICU patients of Zhejiang Province: Multicenter, prospective, observational research 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

浙江省ICU患者深静脉血栓防治的现状研究 

Scientific title:

The prevention and treatment of deep venous thrombosis in ICU patients of Zhejiang Province: Multicenter, prospective, observational research 

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:

李莉 

研究负责人:

李莉 

Applicant:

Li Li 

Study leader:

Li Li 

申请注册联系人电话:

Applicant telephone:

+86 13666604253 

研究负责人电话:

Study leader's telephone:

+86 13666604253 

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:

lilihbch@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lilihbch@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:

杭州市西湖区灵隐路12号 

研究负责人通讯地址:

杭州市西湖区灵隐路12号 

Applicant address:

12 Lingyin Road, Hangzhou, Zhejiang, China 

Study leader's address:

12 Lingyin Road, Hangzhou, Zhejiang, 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:

 

申请人所在单位:

浙江医院 

Applicant's institution:

Zhejiang Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

浙江医院 

Primary sponsor:

Zhejiang Hospital 

研究实施负责(组长)单位地址:

杭州市西湖区灵隐路12号 

Primary sponsor's address:

12 Lingyin Road, Hangzhou, Zhejiang, 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):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江医院

具体地址:

杭州市西湖区灵隐路12号

Institution
hospital:

Zhejiang Hospital

Address:

12 Lingyin Road, Hangzhou, Zhejiang, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

深静脉血栓 

Target disease:

deep venous thrombosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

观察浙江省ICU患者深静脉血栓防治的现状 

Objectives of Study:

To observation the present status of Prevention and treatment of deep venous thrombosis in ICU patients of Zhejiang Province 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

年龄大于18岁的ICU患者,且签署知情同意书。 

Inclusion criteria

ICU patients older than 18 years of old and signed informed consent. 

排除标准:

入住ICU前已经被确诊为DVT或肺栓塞。 

Exclusion criteria:

DVT or pulmonary embolism has been diagnosed before admission to the ICU. 

研究实施时间:

Study execute time:

From2019-09-09To 2020-02-09 

干预措施:

Interventions:

组别:

Case series

样本量:

3000

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

No

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):

浙江医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省中医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Zhejiang University School of Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Provincial People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

杭州市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou First People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省立同德医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Tongde Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Provincial Hospital of Integrated Traditional Chinese and Western Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

杭州师范大学医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Hangzhou Normal University School of Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

杭州市中医院 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

杭州市萧山区第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

First People's Hospital of Xiaoshan District, Hangzhou  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

深静脉血栓

指标类型:

主要指标 

Outcome:

VTE

Type:

Primary indicator 

测量时间点:

60天

测量方法:

超声

Measure time point of outcome:

60 d

Measure method:

指标中文名:

生存率

指标类型:

次要指标 

Outcome:

Survival

Type:

Secondary indicator 

测量时间点:

60天

测量方法:

Measure time point of outcome:

60d

Measure method:

指标中文名:

ICU住院时间

指标类型:

次要指标 

Outcome:

longth of ICU stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总住院天数

指标类型:

次要指标 

Outcome:

Total hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28天生存率

指标类型:

主要指标 

Outcome:

survival rate

Type:

Primary indicator 

测量时间点:

28d

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺栓塞

指标类型:

附加指标 

Outcome:

pulmonary embolism

Type:

Additional indicator 

测量时间点:

60天

测量方法:

Measure time point of outcome:

60d

Measure method:

指标中文名:

凝血功能障碍

指标类型:

副作用指标 

Outcome:

coagulopathy

Type:

Adverse events 

测量时间点:

60天

测量方法:

Measure time point of outcome:

60d

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 99 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):

没有

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

NO

盲法:

没有

Blinding:

NO

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

https://study.cims-medtech.com/C000/Default.aspx

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

https://study.cims-medtech.com/C000/Default.aspx

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,EDC

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

CRF,EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-05
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