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A medical records based study for risk factors of deep venous thrombosis in patients undergoing total joint arthroplasty
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注册号:

Registration number:

ChiCTR2100054844 

最近更新日期:

Date of Last Refreshed on:

2021-12-28 

注册时间:

Date of Registration:

2021-12-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

下肢关节置换术患者术前深静脉血栓形成危险因素分析:基于病历记录的研究 

Public title:

A medical records based study for risk factors of deep venous thrombosis in patients undergoing total joint arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

下肢关节置换术患者术前深静脉血栓形成危险因素分析 

Scientific title:

Risk factors of deep venous thrombosis in patients undergoing total joint arthroplasty 

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:

熊小娟 

研究负责人:

熊小娟 

Applicant:

Xiaojuan Xiong 

Study leader:

Xiaojuan Xiong 

申请注册联系人电话:

Applicant telephone:

15683801907 

研究负责人电话:

Study leader's telephone:

15683801907 

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:

742213249@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

742213249@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:

重庆市渝中区大坪长江支路10号 

研究负责人通讯地址:

重庆市渝中区大坪长江支路10号 

Applicant address:

Department of Anesthesiology, Army Medical Center of PLA, Daping Hospital, Army Medical University, 10 ChangjiangZhilu, Yuzhong District, Chongqing 

Study leader's address:

Department of Anesthesiology, Army Medical Center of PLA, Daping Hospital, Army Medical University, 10 ChangjiangZhilu, Yuzhong District, Chongqing 

申请注册联系人邮政编码:

Applicant postcode:

400042 

研究负责人邮政编码:

Study leader's postcode:

400042 

申请人所在单位:

陆军特色医学中心(大坪医院) 

Applicant's institution:

Staff 

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:

2021(288) 

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:

中国人民解放军陆军特色医学中心伦理委员会 

Name of the ethic committee:

Ethics Committee of Army Medical Center of PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-12-13 

伦理委员会联系人:

范士志 

Contact Name of the ethic committee:

Zhishi Fan 

伦理委员会联系地址:

重庆市渝中区大坪长江支路10号 

Contact Address of the ethic committee:

Army Medical Center of PLA, Daping Hospital, Army Medical University, 10 ChangjiangZhilu, Yuzhong District, Chongqing 

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:

陆军特色医学中心(大坪医院) 

Primary sponsor:

None 

研究实施负责(组长)单位地址:

重庆市渝中区大坪长江支路10号 

Primary sponsor's address:

None 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

Chongqing

市(区县):

Chongqing

Country:

中国

Province:

Chongqing

City:

Chongqing

单位(医院):

陆军特色医学中心

具体地址:

重庆市渝中区大坪长江支路10号

Institution
hospital:

Army Medical Center of PLA

Address:

Army Medical Center of PLA, Daping Hospital, Army Medical University, 10 ChangjiangZhilu, Yuzhong District, Chongqing

经费或物资来源:

None 

Source(s) of funding:

None 

研究疾病:

下肢关节置换术患者术前深静脉血栓形成 

Target disease:

deep venous thrombosis in patients undergoing total joint arthroplasty 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

我们检索文献发现,术前贫血、血小板增多等可调控因素,可能是围术期深静脉血栓形成的高危因素,我们选择贫血等术前合并症,通过不同程度贫血对围术期深静脉血栓形成的高危因素验证,分析贫血这些高危因素与深静脉血栓形成的关系,早期识别高危人群并进行干预,进一步降低围术期深静脉血栓的发生率。 

Objectives of Study:

Retrieval of literature, we found that the regulatory factors including preoperative anemia, thrombocytosis, may be the perioperative risk factor of deep vein thrombosis, we choose the preoperative complications such as anemia, by different degree of anemia on perioperative risk factor of deep vein thrombosis test, analysis of anemia these risk factors and the relationship between deep vein thrombosis. In order to identify high-risk groups early and intervene to further reduce the incidence of perioperative deep vein thrombosis. 

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:

2017年01月-2021年12月所有于我院行下肢关节置 换术的所有患者。 

Inclusion criteria

From January 2017 to December 2021, all patients underwent TJA in our hospital. 

排除标准:

术前未行下肢深静脉彩超的患者和术前未行血常规检查 的患者。 

Exclusion criteria:

Patients who did not receive doppler ultrasound of deep vein of lower limbs and patients who did not receive routine blood examination before TJA surgery. 

研究实施时间:

Study execute time:

From2022-01-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2022-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

血栓组和非血栓组

样本量:

2600

Group:

DVT and None-DVT group

Sample size:

干预措施:

下肢血管超声

干预措施代码:

Intervention:

Ultrasound of lower limb vessels

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

Chongqing 

市(区县):

Chongqing 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

陆军特色医学中心大坪医院 

单位级别:

陆军军医大学附属第三医院 

Institution
hospital:

Army Medical Center of PLA  

Level of the institution:

The third affiliated hospital of the Army Medical University 

测量指标:

Outcomes:

指标中文名:

血栓形成

指标类型:

主要指标 

Outcome:

DVT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

贫血

指标类型:

主要指标 

Outcome:

贫血

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:

信息

组织:

Sample Name:

information

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 100 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):

None

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

No

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

No

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:

No

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

No

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2021-12-28
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