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口服对比局部氨甲环酸在非止血带下快速康复全膝关节置换术中的应用
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注册号:

Registration number:

ChiCTR-INR-17010968 

最近更新日期:

Date of Last Refreshed on:

2018-03-11 

注册时间:

Date of Registration:

2017-07-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

口服对比局部氨甲环酸在非止血带下快速康复全膝关节置换术中的应用 

Public title:

Comparison of oral versus intra-articular tranexamic acid in enhanced-recovery primary total knee arthroplasty without tourniquet application: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

口服对比局部氨甲环酸在非止血带下快速康复全膝关节置换术中的应用 

Scientific title:

Comparison of oral versus intra-articular tranexamic acid in enhanced-recovery primary total knee arthroplasty without tourniquet application: a randomized controlled trial 

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:

王浩洋 

研究负责人:

周宗科 

Applicant:

Wang Haoyang 

Study leader:

Zhou Zongke 

申请注册联系人电话:

Applicant telephone:

+86 13551067110 

研究负责人电话:

Study leader's telephone:

+86 18980601028 

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:

414378748@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zongke@126.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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2012-268 

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:

四川大学华西医院临床试验与生物医学伦理专委会 

Name of the ethic committee:

Clinical Research and Biomedical Ethical Committee of West China hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

卫生部行业科研专项基金 

Source(s) of funding:

Ministry of Health Special Scientific Research Projects of China 

研究疾病:

髋关节骨关节炎 

Target disease:

Hip osteoarthritis 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

全膝关节置换术后出血的重要原因是止血带效应所导致的纤溶亢进,通过使用抗纤溶药物--氨甲环酸减少围术期出血量越来越受到重视。本临床试验通过随机对照研究的方式,探讨口服和局部使用氨甲环酸对减少全膝关节置换术失血量的有效性和安全性。 

Objectives of Study:

Tranexamic acid is an antifibrinolytic agent that activates plasminogen and stops bleeding by inducing blood clot formation. This drug is attached more importance to reducing blood loss in total knee arthroplasty recently. The purpose of this randomized controlled study is to prospective assess the effectiveness and safty of intravenous combined with oral vs topical use Tranexamic on reducing blood loss in total knee arthroplasty.  

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:

研究期内在我院接受初次全膝关节置换手术的所有患者 

Inclusion criteria

All patients undergoing primary total knee arthroplasty during study period  

排除标准:

氨甲环酸过敏的患者;术前肝肾功能障碍的患者;既往7天内有抗凝药物使用史的患者;既往诊断为纤溶异常或患有血液方面疾病患者;有脑血管意外、心肌梗死、纽约心脏协会心衰分级为III到IV级、心房颤动、深静脉血栓或肺栓塞、INR>1.4、活化部分凝血酶原时间>正常值1.4倍、血小板计数<140000/mm3等病史的患者。 

Exclusion criteria:

allergy to tranexamic acid; preoperative hepatic or renal dysfunction; preoperative use of anticoagular medication seven days prior to surgery; history of fibrinolytic disorder or blood dyscrasia; cerebrovascular accident, myocardial infarction, New York heart association class III or IV heart failure, atrial fibrillation, history of deep vein thrombosis or pulmonary embolus, preoperative INR >1.4, aPTT >1.4 x normal, platelets <140000/mm3. 

研究实施时间:

Study execute time:

From2017-03-01To 2017-07-01 

干预措施:

Interventions:

组别:

A

样本量:

75

Group:

A

Sample size:

干预措施:

口服

干预措施代码:

Intervention:

Oral TXA

Intervention code:

组别:

B

样本量:

75

Group:

B

Sample size:

干预措施:

局部氨甲环酸

干预措施代码:

Intervention:

Topical TXA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血色素水平

指标类型:

主要指标 

Outcome:

haemoglobin level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失血量(显性;隐性)

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:

红细胞压积

指标类型:

次要指标 

Outcome:

Hct

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

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:

血沉,C反应蛋白,白介素6

指标类型:

次要指标 

Outcome:

ESR, CRP, IL-6

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

围术期并发症:深静脉血栓和肺栓塞

指标类型:

次要指标 

Outcome:

perioperative complications: deep vein thrombosis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

次要指标 

Outcome:

cost

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肢体肿胀

指标类型:

次要指标 

Outcome:

sweeling

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶心呕吐

指标类型:

次要指标 

Outcome:

nausea and vomiting

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

引流量

指标类型:

次要指标 

Outcome:

drainage

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

length of 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:

疼痛评分

指标类型:

次要指标 

Outcome:

pain

Type:

Secondary 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 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):

非手术人员和结果测量人员通过计算机产生随机编码

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

non-surgical or outcome measurement person use computer-generated list technique

盲法:

Blinding:

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:

试验完成后6个月内公开/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):

2018-2通过ResMan

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

IPD will be public accessable via ResMan from Feb., 2018

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:

excel

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

excel

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-07-23
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