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The evaluation of C-reactive protein, erythrocyte sedimentation rate and procalcitonin in patients with peptic ulcer complicated with hemorrhage
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注册号:

Registration number:

ChiCTR1900027962 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

C-反应蛋白、红细胞沉降率及降钙素原对消化性溃疡并出血患者病情活动程度的评估 

Public title:

The evaluation of C-reactive protein, erythrocyte sedimentation rate and procalcitonin in patients with peptic ulcer complicated with hemorrhage 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

C-反应蛋白、红细胞沉降率及降钙素原对消化性溃疡并出血患者病情活动程度的评估 

Scientific title:

The evaluation of C-reactive protein, erythrocyte sedimentation rate and procalcitonin in patients with peptic ulcer complicated with hemorrhage 

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:

牛思佳 

研究负责人:

牛思佳 

Applicant:

Sijia Niu 

Study leader:

Sijia Niu 

申请注册联系人电话:

Applicant telephone:

+86 13654551960 

研究负责人电话:

Study leader's telephone:

+86 13654551960 

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:

niusjia@163.com 

研究负责人电子邮件:

Study leader's E-mail:

niusjia@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:

黑龙江省哈尔滨市南岗区邮政街23号住院部2号楼12层消化内科医生办公室 

研究负责人通讯地址:

黑龙江省哈尔滨市南岗区邮政街23号住院部2号楼12层消化内科医生办公室 

Applicant address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, China 

Study leader's address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, 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:

哈尔滨医科大学附属第一医院 

Applicant's institution:

Department of Gastroenterology, the First Affiliated Hospital of Harbin 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:

哈医一科研/文章 伦审2019127 

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:

哈尔滨医科大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Harbin Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-12 

伦理委员会联系人:

崔晶微 

Contact Name of the ethic committee:

Jingwei Cui 

伦理委员会联系地址:

黑龙江省哈尔滨市南岗区邮政街23号 

Contact Address of the ethic committee:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, 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:

哈尔滨医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Harbin Medical University.  

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市南岗区邮政街23号 

Primary sponsor's address:

23 Youzheng Street, Nangang District, Harbin, Heilongjiang, 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):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

哈尔滨医科大学附属第一医院

具体地址:

南岗区邮政街23号

Institution
hospital:

The First Affiliated Hospital of Harbin Medical University.

Address:

23 Youzheng Street, Nangang District

经费或物资来源:

哈尔滨医科大学创新科学研究资助项目 

Source(s) of funding:

Harbin Medical University Innovation Research Funding Project 

研究疾病:

消化性溃疡 

Target disease:

Peptic ulcer 

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:

本项目拟研究炎症相关指标(CRP、ESR、PCT)与已合并消化道出血的消化性溃疡活动程度及愈合程度的相互关系,建立炎症相关指标作为消化性溃疡的活动程度及愈合程度的评估指标体系,减少因反复复查胃镜给患者带来的身体及心理的痛苦及经济负担,增加患者的满意度。 

Objectives of Study:

This project was to evaluate the relationship between inflammation-related factors (CRP, ESR, PCT) and the activity and healing degree of peptic ulcer that has been complicated with hemorrhage, and establish inflammation-related factors as indicators for evaluating the activity and healing degree of peptic ulcer system to reduce the physical and psychological pain and economic burden caused by repeated review of gastroscopy and increase patient satisfaction. 

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:

1、年龄≥18且<90岁; 2. 消化道出血患者住院24小时内拟行胃镜检查。 

Inclusion criteria

1. Aged >= 18 and <90 years; 2. Patients with gastrointestinal bleeding plan to have gastroscopy within 24 hours of hospitalization. 

排除标准:

1、近2周内合并可影响CRP、ESR、PCT指标数值的活动期疾病; 2、有胃镜禁忌症的患者; 3、入组前后7天内应用过抗炎药物的患者。 

Exclusion criteria:

1. Patients with active disease that could affect the values of CRP, ESR, and PCT in the past 2 weeks; 2. Patients with gastroscopy contraindications; 3. Patients who have used anti-inflammatory drugs within 7 days before and after enrollment. 

研究实施时间:

Study execute time:

From2019-12-06To 2020-02-06 

干预措施:

Interventions:

组别:

Forrest I级组

样本量:

20

Group:

Forrest I

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

Forrest II级组

样本量:

20

Group:

Forrest II

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

Forrest III级组

样本量:

20

Group:

Forrest III

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

C反应蛋白检测值

指标类型:

主要指标 

Outcome:

C-reactive protein test value

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红细胞沉降率检测值

指标类型:

主要指标 

Outcome:

erythrocyte sedimentation rate test value

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

降钙素原检测值

指标类型:

主要指标 

Outcome:

Procalcitonin test value

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 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):

未应用到随机方法

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

None

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):

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):

待定

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

it has yet to be determined

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:

由Excel保存及管理数据

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

The data will be stored through Excel

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-12-07
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