ChiCTR-IOR-16008362 版本V1.0 版本创建时间2016/4/26 16:25:48 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-IOR-16008362 

最近更新时间:

Date of Last Refreshed on:

2016/4/26 16:24:44 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

针刺治疗中等量丘脑出血的随机对照研究 

Public title:

Acupuncture for moderate thalamic hemorrhage: a randomized ,controlled trial 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

针刺治疗中等量丘脑出血的随机对照研究 

Scientific title:

Acupuncture for moderate thalamic hemorrhage: a randomized ,controlled trial 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

王成伟 

研究负责人:

王成伟 

Applicant:

Chengwei Wang 

Study leader:

Chengwei Wang 

申请注册联系人电话:

Applicant telephone:

+86 13808196160 

研究负责人电话:

Study leader's telephone:

+86 13808196160 

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:

21270526@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

21270526@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:

成都市国学巷37号 

研究负责人通讯地址:

成都市国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, 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:

四川大学华西医院中西医结合科 

Applicant's institution:

Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan 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:

2016-44 

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:

四处大学华西医院生物医学伦理委员会 

Name of the ethic committee:

Clinical research and biomedical ethics committee of West China Hospital, Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

四川大学华西医院中西医结合科 

Primary sponsor:

Department of Integrated Traditional Chinese and western,West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川成都市国学巷37号 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, 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):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

成都市国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

自筹 

Source(s) of funding:

self-finacing 

研究疾病:

丘脑出血 

Target disease:

thalamic hemorrhage 

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:

1.观察针刺急性期干预治疗对中等量丘脑出血的神经功能预后的影响; 2.观察针刺干预对急性中等量丘脑出血的安全性 

Objectives of Study:

1.To observe the effect on neural functional prognosisof moderate thalamic hemorrhage by the intervention of acupuncture in acute stage; 2. To assess the safety of acupuncture for moderate thalamic hemorrhage; 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.首次发生的被CT或MRI证实的丘脑出血患者; 2.中等量丘脑出血患者(10-30ml); 3.单侧的丘脑出血; 4.血肿始发于丘脑; 5.年龄在18-70岁之间; 6.针刺操作可在发病后72小时内进行者; 7.自愿参加本次试验并签署知情同意书者; 

Inclusion criteria

(1) A first ever TH verified by computed tomography (CT) or magnetic resonance imaging (MRI) ; (2) Patients with moderate TH (1030ml); (3) Unilateral primary TH; (4) Hematoma originates from thulums; (5) Aged between 18 and 70 years; (6) Acupuncture treatment can be applied within 72h after TH; (7) Participation is voluntary and the informed consent form is signed. 

排除标准:

(1)创伤性丘脑出血; (2)双侧的丘脑出血; (3)经CT/MRI判断,血肿始发于丘脑以外部位,后累及丘脑; (4)从CT/MRI判断,无法估计血肿原始的位置; (5)患者合并丘脑以外其它部位的出血以及或合并被CT或MRI证实的脑部肿瘤、脑梗死; (6)少量丘脑出血(< 10毫升)或大量丘脑出血(> 30毫升); (7)生命体征不稳定合并心、肾功能不全; (8)法律规定的残疾患者(盲,聋,哑,智力障碍,精神障碍及由其它原因引起的肢体残疾影响到神经功能缺损评价者) (9)患者拒绝签署书面知情同意或拒绝参加本次试验; 

Exclusion criteria:

(1) traumatic TH; (2) bilateral TH; (3) primary hematoma of another location extending to the thalamus; (4) judging by CT/MRI, unable to estimate the location of hematoma originating ; (5) Patients with cerebral infarction, cerebral hemorrhage of another location, or other brain tumors diagnosed on the basis of skull CT or MRI; (6) patients with minor TH (<10ml) or with large TH(>30ml); (7) heart, liver, or renal failure; (8) patients with disability (blind, deaf, dumb, mental retardation, mental disorder, etc.) or on the conditions with limp, osteoarthritis, rheumatoid arthritis, gouty arthritis and other physical activities which may affect the neurological assessment; (9) patients who refuse to sign the written informed consent or did not coordinate with the randomized enrollment; 

研究实施时间:

Study execute time:

From2016-07-01To 2017-12-31 

干预措施:

Interventions:

组别:

观察组

样本量:

244

Group:

study group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

对照组

样本量:

244

Group:

control group

Sample size:

干预措施:

非针刺

干预措施代码:

Intervention:

no acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

NIHSS评分的变化

指标类型:

主要指标 

Outcome:

changes in the National Institutes of Health Stroke Scale 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:

死亡或重度残疾

指标类型:

次要指标 

Outcome:

death or major disability

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术发生率

指标类型:

次要指标 

Outcome:

the rate of shift to surgery

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

格拉斯哥结局量表

指标类型:

次要指标 

Outcome:

the Glasgow Outcome Scale (GOS)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

波士顿诊断性失语测试

指标类型:

次要指标 

Outcome:

boston diagnostic aphasia exam

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

波士顿成套失语测试

指标类型:

次要指标 

Outcome:

boston aphasia battery test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蒙特维尔加高水平语言筛查测试

指标类型:

次要指标 

Outcome:

Mount Wilga high level language screening test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

行为性忽视测试

指标类型:

次要指标 

Outcome:

behavioral in-attention test

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:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

将通过计算机通过PEMS3.1软件生成的随机序列号,隐藏分配将通过一个指定的人员不允许接触病人进行

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

The randomization sequence will be computer-generated by independent researcher using software called Package for Encyclopaedia Medical Statistics 3.1 (PEMS 3.1). Stratification will not be performed in this trial. Concealed allocation will be achieved by an assigned researcher unallowed to contact with patients.

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

2018-1,通过临床试验公共平台ResMan公布,公众可以根据ID号查询

Data management Institution:

In January, 2018,All the data in the form of a survey report released.The people can access the results by ResMan

资料分析单位:

采用病例报告表(CRF)的形式记录所有的数据

Data analysis Institution:

Use the form of case report form records all of the data

注册人:

Name on Registration:

 2016-04-26