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Research on thrombolysis thrapy in acute ischemic stroke
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注册号:

Registration number:

ChiCTR-TRC-10001745 

最近更新日期:

Date of Last Refreshed on:

2015-07-24 

注册时间:

Date of Registration:

2010-08-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

急性缺血性卒中的动脉溶栓试验的研究 

Public title:

Research on thrombolysis thrapy in acute ischemic stroke 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

急性缺血性卒中的动脉溶栓试验的研究 

Scientific title:

Research on thrombolysis thrapy in acute ischemic stroke 

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:

贾建平 

研究负责人:

贾建平 

Applicant:

Jianping Jia 

Study leader:

Jianping Jia 

申请注册联系人电话:

Applicant telephone:

+86 13699225589 

研究负责人电话:

Study leader's telephone:

+86 13911052899 

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:

jiajp.xw@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

jiajp.xw@gmail.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:

北京市西城区长椿街45号 

研究负责人通讯地址:

北京市西城区长椿街45号 

Applicant address:

45 Changchun Street, Xicheng District, Beijing 

Study leader's address:

45 Changchun Street, Xicheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100000 

研究负责人邮政编码:

Study leader's postcode:

100000 

申请人所在单位:

首都医科大学宣武医院 

Applicant's institution:

Xuanwu Hospital, Capital Medical 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:

N/A 

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:

首都医科大学宣武医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Xuanwu Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2006-12-26 

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:

首都医科大学宣武医院 

Primary sponsor:

Xuanwu Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区长椿街45号宣武医院,100053 

Primary sponsor's address:

45 Changchun Street, Xicheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家科技部

具体地址:

北京市复兴路乙15号

Institution
hospital:

Chinese Ministry of Science and Technology

Address:

15B, Fuxing Road, Beijing, 100862, China

经费或物资来源:

国家“十五”科技攻关课题 

Source(s) of funding:

National Key Technology R&D Program 

研究疾病:

急性脑梗死 

Target disease:

Acute ischemic stroke 

研究疾病代码:

ICD:I63.9 

Target disease code:

ICD:I63.9 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

探讨和比较急性脑梗死患者静脉和动脉溶栓及应用尿激酶和rt-PA的疗效及其安全性 

Objectives of Study:

To compare the efficacy and safety of the thrombolysis with urokinase and rt-PA in acute ischemic stroke. 

药物成份或治疗方案详述:

尿激酶,重组型纤溶酶原激活物 

Description for medicine or protocol of treatment in detail:

Urokinase, recombinant tissue plasminogenactivator(rtPA) 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄18~80岁;(2)临床明确诊断急性缺血性卒中[5],并且造成明确的神经功能障碍(NIHSS >4分);(3)症状开始出现至溶栓干预时间≤9h,对于3h以内患者组,在充分影像学支持[指经急诊平扫CT,有条件时做CTP、MR(T1、T2、DWI、PWI)等影像学检查排除梗塞、出血、梗塞后出血转化等情况]下,以静脉溶栓为主;对于3-6h患者组,在影像学支持情况下(同上),根据患者的具体情况和医院的条件,一般情况下按照静脉-动脉-静脉的分配方式对连续的患者施静脉或动脉溶栓;对于6-9h,在影像学支持情况下(同上,此外尚有数字减影血管造影(DSA)发现与神经功能障碍相一致的血管分布区血栓证据,且DSA的TICI分级<2级),原则上动脉溶栓;(4)患者或家属对静脉溶栓的收益/风险知情同意;患者或家属对动脉溶栓的收益/风险知情同意。 关于rt-PA和尿激酶在各个时间窗中的应用,一般情况下按照rt-PA-UK-rt-PA的交替对连续的患者进行分配。在具体实施过程中,如果患者或其家属坚持提出应用rt-PA或尿激酶,可根据情况做出分配调整。 

Inclusion criteria

1. Age 18-80 years; 2. Diagnosed as acute ischemic stroke and specific neurological deficits (NIHSS >4); 3. Onset to Intervention time <=9 hours; 4. Signed the informed consent. 

排除标准:

(1)CT有明确的颅内出血证据,或临床上怀疑为蛛网膜下腔出血(无论CT有无阳性发现);(2)神经功能障碍非常轻微或迅速改善;或昏迷或NIHSS >25分;(3)此次卒中过程中有明确的痫性发作;(4)既往有颅内出血史、动静脉畸形史或颅内动脉瘤史;最近3月内有颅内手术史、严重的头部外伤史、卒中史;最近3周内有消化道、泌尿系统等内脏器官的活动性出血史;最近2周内有外科手术史;最近1周内有腰穿史或动脉穿刺史;(5)明确的颅内出血倾向(PLT<100,100/mm3;48小时内接受肝素治疗,且APTT高于正常上限;最近接受抗凝治疗,并且INR>正常的1.5倍);(6)血压难以控制在180/100mmHg以下;血糖<2.7mmol/L或>22.2mmol/L;(7)CT显示低密度>1/3MCA区域(MCA区脑梗死);(8)严重的肝肾疾病;或伴发其他严重疾患,预计生存年限<1年;(9)动脉溶栓者造影剂过敏;(10)患者或家属不同意溶栓治疗,未签属知情同意书。 

Exclusion criteria:

1. Evidence of intracranial hemorrhage on manifestation or CT; 2. Slight neurological deficits or coma or NIHSS >25; 3. Complicated with seizure; 4. Past history of intracranial hemorrhage, arteriovenous malformation or intracranial aneurysm,or trauma, surgery or active hemorrhage of internal organs,; 5. Inclination of bleeding: PLT<100,100/mm3; accepted heparin therapy within 48 hours, APTT> normal upper limit, INR>1.5; 6. Blood pressure>180/100mmHg, Serum glucose <2.7mmol/Lor >22.2mmol/L; 7. CT shows lower attenuation >1/3MCA area; 8. Complicated with severe hepatic, renal and other disease or other malignant tumor and survival<1 year; 9. Allergic to the contrast medium; 10. Without the informed consent signed. 

研究实施时间:

Study execute time:

From2004-09-01To 2006-12-31 

干预措施:

Interventions:

组别:

1

样本量:

42

Group:

1

Sample size:

干预措施:

3小时内静脉尿激酶溶栓

干预措施代码:

Intervention:

intravenous thrombolysis with Urokinase within 3h

Intervention code:

组别:

2

样本量:

53

Group:

2

Sample size:

干预措施:

3-6小时静脉尿激酶溶栓

干预措施代码:

Intervention:

intravenous thrombolysis with Urokinase within 3-6

Intervention code:

组别:

3

样本量:

21

Group:

3

Sample size:

干预措施:

6-9小时静脉尿激酶溶栓

干预措施代码:

Intervention:

intravenous thrombolysis with Urokinase within 6-9

Intervention code:

组别:

4

样本量:

44

Group:

4

Sample size:

干预措施:

3小时内静脉rtPA溶栓

干预措施代码:

Intervention:

intravenous thrombolysis with rtPA within 3h

Intervention code:

组别:

5

样本量:

59

Group:

5

Sample size:

干预措施:

3-6小时静脉rtPA溶栓

干预措施代码:

Intervention:

intravenous thrombolysis with rtPA within 3-6h

Intervention code:

组别:

6

样本量:

27

Group:

6

Sample size:

干预措施:

6-9小时静脉trPA溶栓

干预措施代码:

Intervention:

intravenous thrombolysis with rtPA within 6-9h

Intervention code:

组别:

7

样本量:

12

Group:

7

Sample size:

干预措施:

3小时内动脉内尿激酶溶栓

干预措施代码:

Intervention:

intra-arterial thrombolysis with Urokinase within 3 hours

Intervention code:

组别:

8

样本量:

68

Group:

8

Sample size:

干预措施:

3-6小时动脉内尿激酶溶栓

干预措施代码:

Intervention:

intra-arterial thrombolysis with Urokinase within 3-6 hours

Intervention code:

组别:

9

样本量:

42

Group:

9

Sample size:

干预措施:

6-9小时动脉内尿激酶溶栓

干预措施代码:

Intervention:

intra-arterial thrombolysis with Urokinase within 6-9 hours

Intervention code:

组别:

10

样本量:

14

Group:

10

Sample size:

干预措施:

3小时内动脉内rtPA溶栓

干预措施代码:

Intervention:

intra-arterial thrombolysis with rtPA within 3h

Intervention code:

组别:

11

样本量:

71

Group:

11

Sample size:

干预措施:

3-6小时内动脉内rtPA溶栓

干预措施代码:

Intervention:

intra-arterial thrombolysis with rtPA within 3-6h

Intervention code:

组别:

12

样本量:

65

Group:

12

Sample size:

干预措施:

6-9小时内动脉内rtPA溶栓

干预措施代码:

Intervention:

intra-arterial thrombolysis with rtPA within 3-6h

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学宣武医院 

单位级别:

三甲 

Institution
hospital:

Xuanwu Hospital, Capital Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

jilin 

City:

changchun 

单位(医院):

吉林大学第一医院 

单位级别:

三甲 

Institution
hospital:

First Hospital of Jilin University  

Level of the institution:

Tertiary A hospital 

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):

广东省中医院 

单位级别:

三甲 

Institution
hospital:

Guangdong hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军第306医院 

单位级别:

三甲 

Institution
hospital:

The 306th Hospital of PLA  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

新疆 

市(区县):

乌鲁木齐 

Country:

China 

Province:

xinjiang 

City:

wulumuqi 

单位(医院):

中国人民解放军乌鲁木齐总医院 

单位级别:

三甲 

Institution
hospital:

Urumqi Hospital of PLA  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市环湖医院 

单位级别:

三甲 

Institution
hospital:

Tianjing Huanhu Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

鞍山 

Country:

China 

Province:

liaoning 

City:

anshan 

单位(医院):

辽宁省鞍山钢铁集团长甸医院 

单位级别:

三甲 

Institution
hospital:

Changdian Hospital Under the Anshan Iron and Steel Groupcompany  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第三医院 

单位级别:

三甲 

Institution
hospital:

Peking University Third Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

贵州 

市(区县):

贵阳 

Country:

China 

Province:

guizhou 

City:

guiyang 

单位(医院):

贵阳医学院附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of Guiyang Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shagnhai 

City:

 

单位(医院):

第二军医大学长海医院 

单位级别:

三甲 

Institution
hospital:

Changhai Hospital of the Second Military Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

乌鲁木齐 

Country:

China 

Province:

Xinjiang Uyghur Autonomous Region 

City:

wulumuqi 

单位(医院):

新疆医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

First Affiliated Hospital of Xinjiang Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

昆明 

Country:

China 

Province:

yunnan 

City:

kunming 

单位(医院):

昆明医学院附属第二医院 

单位级别:

三甲 

Institution
hospital:

the Second Affiliated Hospital of Kunming Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京朝阳医院 

单位级别:

三甲 

Institution
hospital:

Beijing Chao-Yang Hospital  

Level of the institution:

Tertiary A hospital 

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):

广东省佛山市第一人民医院 

单位级别:

三甲 

Institution
hospital:

the First People's Hospital of Fuoshan  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

changchun 

单位(医院):

吉林省四平市中心医院 

单位级别:

三甲 

Institution
hospital:

Siping Central Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

栓塞发生率

指标类型:

主要指标 

Outcome:

Incidence rate of intracranial hemorrhage in 1 week

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

24h NIHSS评分

指标类型:

主要指标 

Outcome:

24h NIHSS scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗后三个月内mRS <2的率

指标类型:

主要指标 

Outcome:

mRS <2 rate in the 3 months

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

三个月内BI≥75的率

指标类型:

主要指标 

Outcome:

BI>=75 rate in the 3 month

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:

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 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):

分层随机,随机数字表

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

Stratified randomization, random number table was used

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):

首都医科大学宣武医院

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

Xuanwu Hospital, Capital Medical University

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:

首都医科大学宣武医院

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

Xuanwu Hospital, Capital Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-08-15
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