今天是:2019-06-17 星期一

藏族人群髋膝关节置换术后下肢深静脉血栓形成的临床研究
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注册号:

Registration number:

ChiCTR1900020675 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

藏族人群髋膝关节置换术后下肢深静脉血栓形成的临床研究 

Public title:

Clinical Research for the Development of Deep Venous Thrombosis after Hip and Knee Replacement Surgery of the Tibetan People  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

藏族人群髋膝关节置换术后下肢深静脉血栓形成的临床研究 

Scientific title:

Clinical Research for the Development of Deep Venous Thrombosis after Hip and Knee Replacement Surgery of the Tibetan People  

研究课题代号(代码):

Study subject ID:

Q17078 

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:

邓立庆 

研究负责人:

邓立庆 

Applicant:

Deng Liqing 

Study leader:

Deng Liqing 

申请注册联系人电话:

Applicant telephone:

+86 18728486525 

研究负责人电话:

Study leader's telephone:

+86 18728486525 

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:

604982346@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

604982346@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:

四川省成都市洗面桥横街20号 

研究负责人通讯地址:

四川省成都市洗面桥横街20号 

Applicant address:

20 Ximianqiao Cross Street, Chengdu, Sichuan, China 

Study leader's address:

20 Ximianqiao Cross Street, 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:

西藏自治区人民政府驻成都办事处医院 

Applicant's institution:

Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region 

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:

西藏自治区人民政府驻成都办事处医院 

Primary sponsor:

Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region (Hospital.C.T.) 

研究实施负责(组长)单位地址:

四川省成都市洗面桥横街20号 

Primary sponsor's address:

20 Ximianqiao Cross Street, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

西藏自治区人民政府驻成都办事处医院

具体地址:

四川省成都市洗面桥横街20号

Institution
hospital:

Hospital of Chengdu Office of People’s Government of Tibetan Autonomous Region

Address:

20 Ximianqiao Cross Street, Chengdu, Sichuan, China

经费或物资来源:

四川省医学会 

Source(s) of funding:

Sichuan medical association 

研究疾病:

下肢深静脉血栓 

Target disease:

deep vein thrombosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

1).调查研究藏族患者在西藏自治区人民政府驻成都办事处医院行全髋关节置换(total hip arthroplasty,THA)、全膝关节置换(total knee arthroplasty,TKA)术后下肢深静脉血栓(deep vein thrombosis,DVT)的发生率、发生时间和解剖部位分布; 2).比较THA、TKA术后DVT分布的差异; 3).为藏族患者行髋、膝关节置换术后下肢DVT的防治提供理论依据。 

Objectives of Study:

1). Investigate and study the incidence, time and anatomical location distribution of deep vein thrombosis (DVT) in the lower extremities of Tibetan patients after total hip arthroplasty (THA) and total knee arthroplasty (TKA) in the Hospital of Chengdu Office of People’s Government of Tibetan Autonomous Region. 2). Compare the difference of DVT distribution after THA and TKA; 3) to provide theoretical basis for the prevention and treatment of lower limb DVT in Tibetan patients after hip and knee 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:

单臂 

Study design:

Single arm 

纳入标准:

①髋、膝关节初次置换的患者;②术前血小板、凝血指标正常的患者;③均在全麻下手术;④所有患者均在物理预防基础上使用药物预防。 

Inclusion criteria

(1) patients with initial hip and knee joint replacement; (2) patients with normal preoperative platelet and coagulation indexes; (3) are under general anesthesia surgery; (4) all patients in physical prevention on the basis of the use of drug prevention. 

排除标准:

①术前存在深静脉血栓患者;②全髋或全膝关节翻修患者;③抗凝禁忌症的患者(血友病等);④肝素过敏患者;⑤其他疾病需要抗凝治疗的患者(房颤等),合并不能纠正的内分泌、血液、心血管等内科疾病者。⑥精神行为异常、认知障碍患者。 

Exclusion criteria:

(1) Preoperative patients with deep vein thrombosis; (2) Total hip or total knee revision patients; (3) Patients with anticoagulant contraindications (hemophilia, etc.); (4) heparin allergy patients; (5) other diseases need anticoagulant treatment of patients (atrial fibrillation, etc.), can not be corrected by the combination of endocrine, blood, cardiovascular and other medical diseases; (6) mental behavior disorders, cognitive impairment patients. 

研究实施时间:

Study execute time:

From2018-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

200

Group:

Case series

Sample size:

干预措施:

双下肢静脉彩超检查

干预措施代码:

Intervention:

Color doppler ultrasound examination of lower extremity veins

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

西藏自治区人民政府驻成都办事处医院 

单位级别:

三甲医院 

Institution
hospital:

Hospital of Chengdu Office of People’s Government of Tibetan Autonomous Region  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

下肢深静脉血栓的发生率

指标类型:

主要指标 

Outcome:

ncidence of deep venous thrombosis in lower extremity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下肢深静脉血栓的发生时间

指标类型:

主要指标 

Outcome:

The time of occurrence of deep venous thrombosis in the lower extremity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下肢深静脉血栓发生的解剖部位分布

指标类型:

主要指标 

Outcome:

Anatomic distribution of deep venous thrombosis of the lower extremity

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:

下肢静脉

组织:

Sample Name:

Lower limb venous

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 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):

所有符合手术标准的患者术后均纳入试验对象。

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:

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):

2020年6月

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

June 2020

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:

病例记录表

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

casebook

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-01-12
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