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新型冠状病毒肺炎(COVID-19)患者的红细胞沉降率
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注册号:

Registration number:

ChiCTR2000033346 

最近更新日期:

Date of Last Refreshed on:

2020-05-28 

注册时间:

Date of Registration:

2020-05-28 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)患者的红细胞沉降率 

Public title:

Erythrocyte Sedimentation Rate in novel coronavirus pneumonia (COVID-19) patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎(COVID-19)患者的红细胞沉降率 

Scientific title:

Erythrocyte Sedimentation Rate in novel coronavirus pneumonia (COVID-19) patients 

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:

张伟 

研究负责人:

张伟 

Applicant:

Zhang Wei 

Study leader:

Zhang Wei 

申请注册联系人电话:

Applicant telephone:

+86 18985683936 

研究负责人电话:

Study leader's telephone:

+86 18982262419 

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:

zhangwei_hxicu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangwei_hxicu@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:

贵州省遵义市大连路149号 

研究负责人通讯地址:

贵州省遵义市大连路149号 

Applicant address:

149 Dalian Road, Zunyi, Guizhou, China 

Study leader's address:

149 Dalian Road, Zunyi, Guizhou, China 

申请注册联系人邮政编码:

Applicant postcode:

563000 

研究负责人邮政编码:

Study leader's postcode:

563000 

申请人所在单位:

遵义医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Zunyi 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:

KLL-2020-013 

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:

遵义医学院附属医院生物医学研究伦理委员会 

Name of the ethic committee:

The Biomedical Ethics of Affiliated Hospital of Zunyi Medical College 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-11 

伦理委员会联系人:

陈琦 

Contact Name of the ethic committee:

Qi Chen 

伦理委员会联系地址:

贵州省遵义市大连路149号 

Contact Address of the ethic committee:

149 Dalian Road, Zunyi, Guizhou, 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:

遵义医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Zunyi Medical University 

研究实施负责(组长)单位地址:

贵州省遵义市大连路149号 

Primary sponsor's address:

149 Dalian Road, Zunyi, Guizhou, 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):

贵州省

市(区县):

遵义市

Country:

China

Province:

Guizhou

City:

Zunyi City

单位(医院):

遵义医科大学附属医院

具体地址:

遵义市大连路149号

Institution
hospital:

Affiliated Hospital of Zunyi Medical Univeristy

Address:

149 Dalian Road, Zunyi City

经费或物资来源:

贵州省科技厅科技支撑计划与贵州省科技厅重大基础研究计划 

Source(s) of funding:

Department of Science and Technology of Support Plan in Guizhou Province and Department of Science and Technology of Fundamental Research Plan in Guizhou Province 

研究疾病:

COVID-19 Pneumonia 

Target disease:

新冠肺炎 

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:

探索性研究/预试验 

Study phase:

研究目的:

比较新冠肺炎患者血沉增快组与正常组之间的临床特征及流行病学特征之间的差异。 

Objectives of Study:

To compare the clinical characteristics between the faster group and the normal group about erythrocyte sedimentation rate in COVID-19 patients, analyze the variables with significant differences, and explore the influencing factors of faster sedimentation rate. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

住院期间行血沉检测的COVID-19患者 

Inclusion criteria

COVID-19 patients with ESR during hospitalization 

排除标准:

No 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2020-02-29To 2020-05-12 

干预措施:

Interventions:

组别:

血沉增快组vs正常组

样本量:

80

Group:

faster versus normal about erythrocyte sedimentation rate

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):

贵州省 

市(区县):

贵阳市 

Country:

China 

Province:

Guizhou 

City:

Guiyang 

单位(医院):

贵州省职工医院 

单位级别:

三级甲等医院 

Institution
hospital:

Guizhou Provincial Jiangjunshan Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血沉

指标类型:

主要指标 

Outcome:

ESR

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:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

No.

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 6 years
最大 Max age 87 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):

No.

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

当论文发表后在本试验平台发布试验数据

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

When our paper will be pulished in the journal, we are able to share our study data.

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:

我们的数据采集采用EXCEL表格手工录入。

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

Our clinical data were manually obtained from the Hospital Information System by researchers.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-28
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