Today is 2019-12-10

Predictors of mortality of acute ischemic stroke with thrombolytic therapy in Guangzhou, China
download

注册号:

Registration number:

ChiCTR-PRCH-11001279 

最近更新日期:

Date of Last Refreshed on:

2015-07-10 

注册时间:

Date of Registration:

2011-03-27 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中国广州地区急性缺血性脑卒中溶栓后死亡影响因素研究 

Public title:

Predictors of mortality of acute ischemic stroke with thrombolytic therapy in Guangzhou, China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国广州地区急性缺血性脑卒中阿替普酶溶栓后三个月死亡率影响因素研究 

Scientific title:

Predictors of three month mortality of acute ischemic stroke with thrombolytic therapy in Guangzhou, China 

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:

林念童 

研究负责人:

林念童 

Applicant:

Niantong LIN 

Study leader:

Niantong LIN 

申请注册联系人电话:

Applicant telephone:

+86 13922718999 

研究负责人电话:

Study leader's telephone:

+86 13922718999 

申请注册联系人传真 :

Applicant Fax:

+86 20 83062767 

研究负责人传真:

Study leader's fax:

+86 20 83062767 

申请注册联系人电子邮件:

Applicant E-mail:

linnt@139.com 

研究负责人电子邮件:

Study leader's E-mail:

linnt@139.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:

广州越秀区沿江西路151号 

研究负责人通讯地址:

广州越秀区沿江西路151号神经内科一区 

Applicant address:

151 Yanjiangxi Road, Guangzhou 

Study leader's address:

151 Yanjiangxi Road, Guangzhou 

申请注册联系人邮政编码:

Applicant postcode:

510120 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

林念童(广州医学院第一附属神经内科) 

Applicant's institution:

The first affiliated hospital of Guangzhou Medical College 

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:

广州医学院第一附属医院 

Primary sponsor:

The first affiliated hospital of Guangzhou Medical College 

研究实施负责(组长)单位地址:

中国广东省广州市越秀区沿江西路151号 

Primary sponsor's address:

151 Yanjiangxi Road, Guangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

-

Country:

China

Province:

Guangdong

City:

-

单位(医院):

南方医科大学南方医院

具体地址:

广州市广州大道北路1838号

Institution
hospital:

Nan Fang Hospital, Nan Fang Medical University

Address:

1838 Guangzhou Road, Guangzhou City, China

经费或物资来源:

广州医学院第一附属医院 

Source(s) of funding:

The first affiliated hospital of Guangzhou Medical College 

研究疾病:

脑梗塞 

Target disease:

Ischemic stroke 

研究疾病代码:

ICD:I63.9 

Target disease code:

ICD:I63.9 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

急性脑梗塞溶栓后三个月死亡率的临床影响因素 

Objectives of Study:

To investigate predictors of mortality of acute ischemic stroke after 3 months of thrombolytic therapy 

药物成份或治疗方案详述:

爱通立 阿替普酶 

Description for medicine or protocol of treatment in detail:

Actilyse Alteplase 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1、急性脑梗塞; 2、发病72小时内; 3、NIHSS评分4-25分; 4、脑CT或MRI基线无低密度影或可见病灶小于三分之一动脉供血区; 5、使用过阿替普酶治疗; 

Inclusion criteria

1. Acute ischemic stroke; 2. Symptom onset within 72 hours; 3. NIHSS 4-25; 4. Baseline CT or MRI negtive findings or lesion size less than 1/3 of blood supply area; 5. Thrombolytic therapy with rtPA 

排除标准:

1、非急性脑梗塞; 2、未使用溶栓治疗。 

Exclusion criteria:

1. None ischemic stroke; 2. Treated with therapy other than rtPA 

研究实施时间:

Study execute time:

From2010-09-01To 2011-09-30 

干预措施:

Interventions:

组别:

1

样本量:

120

Group:

1

Sample size:

干预措施:

溶栓治疗

干预措施代码:

Intervention:

Thrombolytic therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州医学院第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The first affiliated hospital of Guangzhou Medical College  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

死亡率

指标类型:

主要指标 

Outcome:

mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

barthel index

指标类型:

次要指标 

Outcome:

barthel 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:

mRs

指标类型:

次要指标 

Outcome:

mRs

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 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):

方便选择

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

convenience enrollment

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):

原始数据公开时间:

The time of sharing IPD:

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):

广州医学院第一附属医院

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

The first affiliated hospital of Guangzhou Medical College

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:

广州医学院

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

Guangzhou Medical College

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-03-27
return list