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下肢骨折患者深静脉血栓发生的规律及中医药预防作用的临床研究
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注册号:

Registration number:

ChiCTR1800017754 

最近更新日期:

Date of Last Refreshed on:

2018-08-13 

注册时间:

Date of Registration:

1990-01-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

下肢骨折患者深静脉血栓发生的规律及中医药预防作用的临床研究 

Public title:

A Study for the Regularity of Deep Venous Thrombosis in Patients with Lower Limb Fractures and the Prevention and Treatment of Traditional Chinese Medicine 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

下肢骨折患者深静脉血栓发生的规律及中医药预防作用的临床研究 

Scientific title:

A Study for the Regularity of Deep Venous Thrombosis in Patients with Lower Limb Fractures and the Prevention and Treatment of Traditional Chinese Medicine 

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:

王鹏飞 

研究负责人:

张堃 

Applicant:

Pengfei Wang 

Study leader:

Kun Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13759994007 

研究负责人电话:

Study leader's telephone:

+86 15029219698 

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:

pengfei_wang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hhyyzk@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:

陕西省西安市碑林区友谊东路555号 

研究负责人通讯地址:

陕西省西安市碑林区友谊东路555号 

Applicant address:

555 Youyi Road East, Xi'an, Shaanxi, China 

Study leader's address:

555 Youyi Road East, Xi'an, Shaanxi, 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:

西安市红会医院 

Applicant's institution:

Xi'an Honghui Hospital 

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:

2018-002 

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:

西安交通大学附属红会医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of the Xi'an Honghui Hospital Affiliated to Xi'an Jiaotong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-15 

伦理委员会联系人:

宁宁 

Contact Name of the ethic committee:

Ning Ning 

伦理委员会联系地址:

陕西省西安市碑林区友谊东路555号 

Contact Address of the ethic committee:

555 Youyi Road East, Xi'an, Shaanxi, 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:

西安市红会医院 

Primary sponsor:

Xi'an Honghui Hospital 

研究实施负责(组长)单位地址:

陕西省西安市碑林区友谊东路555号 

Primary sponsor's address:

555 Youyi Road East, Xi'an, Shaanxi, 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):

陕西省

市(区县):

Country:

China

Province:

Shaanxi

City:

单位(医院):

西安市红会医院

具体地址:

西安市碑林区友谊东路555号

Institution
hospital:

Department of Trauma and Orthopedics

Address:

555 Youyi Road East, Xi'an, Shaanxi, China

经费或物资来源:

陕西省重点研发计划项目----下肢骨折患者深静脉血栓发生的时间规律及中医药干预作用的临床研究 

Source(s) of funding:

Shaanxi Province's Key R&D Program--Clinical Study on the Feature of Time of Deep Venous Thrombosis in Patients with Lower Limb Fractures and the Intervention Effect of Chinese Medicine 

研究疾病:

静脉血栓栓塞症 

Target disease:

VTE 

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:

探索性研究/预试验 

Study phase:

研究目的:

1.探讨下肢骨折患者深静脉血栓发生的规律(包括时间规律 部位规律等) 2.探索防治作用的中医药 

Objectives of Study:

1. To discuss the feature of deep venous thrombosis in lower limb(including initial time and location et al) 2. Exploring the prevention of Chinese medicine 

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:

(前期先以髋部骨折开始) 年满 18 周岁以上 伤后24小时内入院髋部骨折患者,拟接受手术治疗 

Inclusion criteria

1. with hip fracture; 2. 18 years of age or older; 3. Received surgical treatment for hip fracture patients admitted within 24 hours after injury. 

排除标准:

受伤时间大于24小时入院患者 住院时间小于48小时 临床明显活动性出血 已知的凝血异常(如血友病) 需要持续抗凝治疗的患者(如机械瓣患者) 严重肝脏、肾脏疾病 有精神疾病等,预期依从性不良的患者 有抗凝药物使用禁忌症 

Exclusion criteria:

1. Injured patients admitted for more than 24 hours; 2. Hospital stay less than 48 hours; 3. Clinically active bleeding; 4. Known coagulation abnormalities (such as hemophilia); 5. Patients requiring continuous anticoagulant therapy (eg, mechanical valve patients); 6. Severe liver and kidney disease; 7. There is mental illness, etc., and patients with poor compliance are expected; 8. There are contraindications to the use of anticoagulant drugs. 

研究实施时间:

Study execute time:

From2018-01-01To 2020-01-01 

征募观察对象时间:

Recruiting time:

From2018-01-01To  

干预措施:

Interventions:

组别:

1

样本量:

100

Group:

1

Sample size:

干预措施:

观察

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

2

样本量:

500

Group:

2

Sample size:

干预措施:

低分子肝素

干预措施代码:

Intervention:

Low molecular weight heparin

Intervention code:

组别:

3

样本量:

100

Group:

3

Sample size:

干预措施:

中药

干预措施代码:

Intervention:

Chinese medicine

Intervention code:

组别:

4

样本量:

100

Group:

4

Sample size:

干预措施:

低分子肝素+中药

干预措施代码:

Intervention:

LMWH+Chinese medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西省 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

西安市红会医院 

单位级别:

三甲 

Institution
hospital:

Department of Trauma and Orthopedics  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

B超

指标类型:

主要指标 

Outcome:

Ultrasound B examination

Type:

Primary indicator 

测量时间点:

入院至出院,每天1次,术后1月 3月

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

使用后保存 

说明

保存2年后销毁

Fate of sample:

Preservation after use 

Note:

Destroyed after 2 years of preservation

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 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):

由统计学专家使用EXCEL表格生成

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

Generated by statistical experts using EXCEL sheet

盲法:

Not stated

Blinding:

Not stated

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):

试验结束后6月公开

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

data will be maken public in 6 months after the end of the trial

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:

CRF AND spss19.0

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

CRF AND spss19.0

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 1990-01-01
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