今天是:2019-12-12 星期四

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 高血压对关节置换术围手术期出血的影响
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注册号:

Registration number:

ChiCTR1900025516 

最近更新日期:

Date of Last Refreshed on:

2019-08-31 

注册时间:

Date of Registration:

2019-08-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 高血压对关节置换术围手术期出血的影响 

Public title:

Effect of hypertension on perioperative bleeding in joint replacement 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

高血压对关节置换术围手术期出血的影响 

Scientific title:

Effect of hypertension on perioperative bleeding in joint replacement 

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:

冯硕 

研究负责人:

陈向阳 

Applicant:

Feng Shuo 

Study leader:

Chen Xiang-yang 

申请注册联系人电话:

Applicant telephone:

+86 18552880088 

研究负责人电话:

Study leader's telephone:

+86 15905201635 

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:

781733181@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1173503735@qq.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:

江苏省徐州市泉山区淮海西路99号 

研究负责人通讯地址:

江苏省徐州市泉山区淮海西路99号 

Applicant address:

99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, China 

Study leader's address:

99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, 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:

徐州医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Xuzhou Medical University 

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:

徐州医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Xuzhou Medical University 

研究实施负责(组长)单位地址:

江苏省徐州市泉山区淮海西路99号 

Primary sponsor's address:

99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

徐州医科大学附属医院

具体地址:

江苏省徐州市泉山区淮海西路99号

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University

Address:

99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, China

经费或物资来源:

无 

Source(s) of funding:

no 

研究疾病:

关节置换 

Target disease:

Arthroplasty 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

高血压对关节置换术围手术期出血的影响 

Objectives of Study:

Effect of hypertension on perioperative bleeding in joint replacement 

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、初次关节置换; 2、高血压组HP≥140/90; 3、非高血压组HP<140/90 

Inclusion criteria

1. Primary joint replacement; 2. Hypertension group HP (> 140/90); 3. Non-hypertensive group HP < 140/90. 

排除标准:

1、关节置换术后翻修; 2、合并有血液系统相关疾病, 凝血功能障碍及其他内科疾病; 3、术前服用阿司匹林等抗凝药物; 4、24 h补液总量超过 2 000 ml。 

Exclusion criteria:

1. Revision after arthroplasty; 2. With blood system related diseases; with coagulation dysfunction and other medical diseases; 3. Preoperative use of anticoagulant drugs such as aspirin; 4. 24 hours of fluid replacement more than 2,000 ml. 

研究实施时间:

Study execute time:

From2019-08-28To 2021-08-28 

干预措施:

Interventions:

组别:

1

样本量:

500

Group:

1

Sample size:

干预措施:

高血压组

干预措施代码:

Intervention:

Hypertension group

Intervention code:

组别:

2

样本量:

500

Group:

2

Sample size:

干预措施:

正常血压组

干预措施代码:

Intervention:

Normal blood pressure group

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

徐州医科大学附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

失血量

指标类型:

主要指标 

Outcome:

blood loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血量

指标类型:

主要指标 

Outcome:

Blood transfusion volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白

指标类型:

主要指标 

Outcome:

Hemoglobin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

围手术期血压

指标类型:

主要指标 

Outcome:

Perioperative blood pressure

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 80 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 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):

发表论文

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

publish papers

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:

徐州医科大学附属医院电子医生站

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

Xuzhou Medical University Affiliated Hospital Electronic Doctor Station

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-31
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