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加速康复模式下氨甲环酸超前抗纤溶对全膝关节置换围手术期效果的研究
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注册号:

Registration number:

ChiCTR2000029720 

最近更新日期:

Date of Last Refreshed on:

2020-02-16 

注册时间:

Date of Registration:

2020-02-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

加速康复模式下氨甲环酸超前抗纤溶对全膝关节置换围手术期效果的研究 

Public title:

Effects of preemptive antifibrinolysis of tranexamic acid in total knee arthroplasty under enhanced recovery after surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

加速康复模式下氨甲环酸超前抗纤溶对类风湿性关节炎患者全膝关节置换围手术期效果的研究 

Scientific title:

Effects of preemptive antifibrinolysis of tranexamic acid in total knee arthroplasty in patients with rheumatoid arthritis under enhanced recovery after surgery 

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:

雷一霆 

研究负责人:

黄伟 

Applicant:

Yiting Lei 

Study leader:

Wei Huang 

申请注册联系人电话:

Applicant telephone:

+86 18584550703 

研究负责人电话:

Study leader's telephone:

+86 17880267665 

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:

leiyit614@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huangw511@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:

重庆市渝中区袁家岗友谊路1号 

研究负责人通讯地址:

重庆市渝中区袁家岗友谊路1号 

Applicant address:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing, China 

Study leader's address:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400016 

研究负责人邮政编码:

Study leader's postcode:

400016 

申请人所在单位:

重庆医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Chongqing 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:

2019-015 

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:

重庆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 Chongqing Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-14 

伦理委员会联系人:

许平 

Contact Name of the ethic committee:

Xu Ping 

伦理委员会联系地址:

重庆市渝中区袁家岗友谊路1号 

Contact Address of the ethic committee:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing, 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:

重庆医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Chongqing Medical University  

研究实施负责(组长)单位地址:

重庆市渝中区袁家岗友谊路1号 

Primary sponsor's address:

1 Youyi Road, Yuanjiagang, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第一医院

具体地址:

渝中区袁家岗友谊路一号

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University

Address:

1 Youyi Road, Yuanjiagang, Yuzhong District

经费或物资来源:

骨科综合微创技术和围手术加速康复技术推广(项目代码:Z135050009017)(2018中央引导地方科技发展专项资金)  

Source(s) of funding:

Special Fund for Local Scientific and Technological Development under the Guidance of the Central Government (Grant No. Z135050009017).  

研究疾病:

类风湿关节炎 

Target disease:

Rheumatoid arthritis  

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

氨甲环酸超前抗纤溶对类风湿性关节炎患者全膝关节置换围手术期失血量及炎性因子的影响。 

Objectives of Study:

This study is designed to compare the effects of preemptive antifibrinolysis of single-dose and repeat-dose intravenous tranexamic acid (IV-TXA) in total knee arthroplasty (TKA) in patients with rheumatoid arthritis (RA).  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 根据1978年美国风湿病协会修订的“类风湿性关节炎分类标准”和2010年美国风湿病学会联合欧洲抗风湿病联盟的类风湿关节炎分类标准,诊断为类风湿性关节炎,同时Kellgren-LawrenceX线分级为Ⅲ或Ⅳ期; 2. 初次单侧TKA手术; 3. 围手术期接受TXA抗纤溶治疗者。  

Inclusion criteria

1. Diagnosed as rheumatoid arthritis according to the "Classification of Rheumatoid Arthritis" revised by the American College of Rheumatology in 1978 and the classification of rheumatoid arthritis by the American College of Rheumatology and the European Union of Rheumatology in 2010. Kellgren-LawrenceX line is graded III or IV; 2. Initial unilateral TKA surgery; 3. Perioperative TXA antifibrinolytic therapy. 

排除标准:

1. 合并患有严重的心血管疾病(如心肌梗死、心房颤动、心绞痛、心力衰竭等)、脑血管疾病(脑梗死、脑出血等)者; 2. 需要长时间口服抗凝药物(如阿司匹林、华法林、氯吡格雷等)者。  

Exclusion criteria:

1. The patients with severe cardiovascular disease (such as myocardial infarction, atrial fibrillation, angina pectoris, heart failure, etc.), cerebrovascular disease (cerebral infarction, brain Bleeding, etc.; 2. Who need long-term oral anticoagulant drugs (such as aspirin, warfarin, clopidogrel, etc.).  

研究实施时间:

Study execute time:

From2020-03-01To 2020-12-30 

征募观察对象时间:

Recruiting time:

From2020-03-01To 2021-03-01 

干预措施:

Interventions:

组别:

对照组

样本量:

39

Group:

control group

Sample size:

干预措施:

NS 100ml i.v. q12h,术前3天至术前

干预措施代码:

Intervention:

NS 100ml i.v. q12h, from 3 days before the operation

Intervention code:

组别:

试验组

样本量:

39

Group:

experimental group

Sample size:

干预措施:

TXA 1.5g i.v. q12h,术前3天至术前

干预措施代码:

Intervention:

TXA 1.5g i.v. q12h, from 3 days before the operation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

总失血量

指标类型:

主要指标 

Outcome:

total 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:

隐性失血

指标类型:

主要指标 

Outcome:

hidden 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:

术中失血

指标类型:

主要指标 

Outcome:

intraoperative 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:

纤溶指标

指标类型:

次要指标 

Outcome:

fibrinolysis index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症指标

指标类型:

次要指标 

Outcome:

inflammatory index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血指标

指标类型:

次要指标 

Outcome:

coagulation indicator

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血栓弹力图

指标类型:

次要指标 

Outcome:

TEG

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗Xa因子水平

指标类型:

次要指标 

Outcome:

antifactor Xa activity

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白降低值

指标类型:

次要指标 

Outcome:

Hb drop

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血率

指标类型:

次要指标 

Outcome:

transfusion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

关节活动度

指标类型:

次要指标 

Outcome:

range of motion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血栓发生率

指标类型:

副作用指标 

Outcome:

incidence of thrombosis (DVT PE)

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

切口相关并发症

指标类型:

副作用指标 

Outcome:

incision related complications

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

再入院率

指标类型:

副作用指标 

Outcome:

readmission rate

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘀斑情况

指标类型:

次要指标 

Outcome:

ecchymosis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

附加指标 

Outcome:

length of stay

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

附加指标 

Outcome:

hospitalization expenses

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

副作用指标 

Outcome:

death

Type:

Adverse events 

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 18 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):

临床研究助理使用电脑产生随机数。

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

The clinical research assistant use the computer to generate the random number.

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

2021年9月,809084355@qq.com

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

September, 2021; 809084355@qq.com

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:

骨科临床数据库

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

Orthopaedic surgery database

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-10
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