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大脑半球大面积脑梗死患者部分颅骨切除减压联合低温治疗研究
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注册号:

Registration number:

ChiCTR-TRC-12002698 

最近更新日期:

Date of Last Refreshed on:

2015-12-16 

注册时间:

Date of Registration:

2012-10-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

大脑半球大面积脑梗死患者部分颅骨切除减压联合低温治疗研究 

Public title:

Decompressive Hemicraniectomy Combined Hypothermia in Malignant Middle Cerebral Artery Infarct 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

大脑半球大面积脑梗死患者部分颅骨切除减压联合低温治疗研究 

Scientific title:

Decompressive Hemicraniectomy Combined Hypothermia in Malignant Middle Cerebral Artery Infarct 

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:

宿英英 

研究负责人:

宿英英 

Applicant:

Su Yingying 

Study leader:

Su Yingying 

申请注册联系人电话:

Applicant telephone:

+86 010 83198475 

研究负责人电话:

Study leader's telephone:

+86 010 83198475 

申请注册联系人传真 :

Applicant Fax:

+86 010 83198475 

研究负责人传真:

Study leader's fax:

+86 010 83198475 

申请注册联系人电子邮件:

Applicant E-mail:

suyingying@xwh.ccmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

suyingying@xwh.ccmu.edu.cn 

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 北京宣武医院 神经内科监护室 

研究负责人通讯地址:

北京市 西城区 长椿街45号 北京宣武医院 神经内科监护室 

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:

100053 

研究负责人邮政编码:

Study leader's postcode:

 

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:

临技审[2010]015号 

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:

2010-03-31 

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 

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:

经费或物资来源:

北京市教育委员会科技发展计划面上项目 

Source(s) of funding:

Research Common Program of Beijing Municipal Commission of Education 

研究疾病:

大面积脑梗死 

Target disease:

Malignant Middle Cerebral Artery Infarct 

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:

其它 

Study phase:

N/A 

研究目的:

血管内低温治疗大面积脑梗死的有效性、可行性和安全性研究 

Objectives of Study:

To assess the effect, availability and safety of hypothermia in malignant middle cerebral artery infarct. 

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:

1.年龄18-80岁;2.发病48小时内;3.NIHSS评分大于等于15(右侧半球)或20分(左侧半球);4.格拉斯哥评分(GCS)小于等于12分;5.梗死面积至少为大脑中动脉区2/3 

Inclusion criteria

1. age 18-80 years; 2. within 48h of stroke onset; 3. NIHSS>=15(right) or 20(left); 4. Glasgow Coma Scale <=12; 5. ischemic signs on CT involving at least 2/3 of the MCA territory. 

排除标准:

1.病前神经系统严重残疾(mRS≥2);2.GCS评分<6(去除语言项);3.预期寿命<6个月;4.妊娠;5.脓毒症;6.CT显示颅内出血、占位和动脉瘤;7.室性心律失常或QT间期>450ms;8.血小板计数<7.5万/mm3 ;9.肾功能不全,Cr>2mg;10.肝功不全,TBIL>30umol;11.盐酸哌替啶(杜冷丁)过敏 

Exclusion criteria:

1. prestroke score on the mRS >2; 2. a GCS score without the verbal response item<6; 3. life expectancy less than 6 months; 4. pregancy; 5. Sepsis; 6. intracranial hemorrhage or intracranial space-occupying lesions or aneurysm; 7. ventricular arrhythmia or QT interal>450ms; 8. blood platelet<75000/mm3; 9. renal insufficiency, Cr>2mg; 10. hepatic insufficiency, TBIL>30umol; 11. Pethidine allergy. 

研究实施时间:

Study execute time:

From2007-08-01To 2012-08-01 

征募观察对象时间:

Recruiting time:

From2007-08-01To 2012-08-01 

干预措施:

Interventions:

组别:

低温组

样本量:

50

Group:

hypothermia

Sample size:

干预措施:

血管内低温及手术

干预措施代码:

Intervention:

Endovascular hypothermia and operation

Intervention code:

组别:

对照组

样本量:

50

Group:

control

Sample size:

干预措施:

手术

干预措施代码:

Intervention:

Operation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

改良Rankin评分

指标类型:

主要指标 

Outcome:

Modified Rankin scale

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):

随机数字表

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

random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-10-11
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