今天是:2019-04-22 星期一

复合手术与传统显微手术治疗脑动脉瘤的随机对照试验
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注册号:

Registration number:

ChiCTR1900022546 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

复合手术与传统显微手术治疗脑动脉瘤的随机对照试验 

Public title:

Efficacy and safety of combined surgery versus microsurgery in the treatment of brain aneurysm: A randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

复合手术与传统显微手术治疗脑动脉瘤:一项前瞻性随机对照试验 

Scientific title:

Efficacy and safety of combined surgery versus microsurgery in the treatment of brain aneurysm: A randomized controlled trial 

研究课题代号(代码):

Study subject ID:

湖北省创新专项重大项目2018ACA139 

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:

辛灿 

研究负责人:

陈劲草 

Applicant:

Can Xin 

Study leader:

Jincao Chen 

申请注册联系人电话:

Applicant telephone:

+86 15927681577 

研究负责人电话:

Study leader's telephone:

+86 027 67813118 

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:

xincanonilne@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

chenjincao2012@hotmail.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:

武汉市武昌区东湖路169号 

研究负责人通讯地址:

武汉市武昌区东湖路169号 

Applicant address:

169 Donghu Road, Wuhan, Hubei, China 

Study leader's address:

169 Donghu Road, Wuhan, Hubei, 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:

武汉大学中南医院神经外科 

Applicant's institution:

Department of Neurosurgery, Zhongnan Hospital of Wuhan University, Wuhan 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:

2018039 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

武汉大学中南医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee, Zhongnan Hospital of Wuhan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-19 

伦理委员会联系人:

武汉大学中南医院医学伦理委员会 

Contact Name of the ethic committee:

Medical Ethics Committee, Zhongnan Hospital of Wuhan University 

伦理委员会联系地址:

武汉市武昌区东湖路169号门诊9楼 

Contact Address of the ethic committee:

Outpatient Building, 9th floor, 169 Donghu Road, Wuchang District, Wuhan, Hubei, 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:

武汉大学中南医院神经外科 

Primary sponsor:

Department of Neurosurgery, Zhongnan Hospital of Wuhan University 

研究实施负责(组长)单位地址:

武汉市武昌区东湖路169号6号楼8楼 

Primary sponsor's address:

Building 6, 8th floor, 169 Donghu Road, Wuchang District, Wuhan, Hubei, 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):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

武汉大学中南医院

具体地址:

武汉市武昌区东湖路169号

Institution
hospital:

Zhongnan Hospital of Wuhan University

Address:

169 Donghu Road, Wuhan, China

经费或物资来源:

湖北省创新专项重大项目2018ACA139 

Source(s) of funding:

Technological Innovation Foundation of Hubei Province (No. 2018ACA139) 

研究疾病:

脑动脉瘤 

Target disease:

brain aneurysm 

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:

验证在复合手术室治疗脑动脉瘤与传统显微手术相比,能够更安全有效的进行手术,患者取得更好的预后。 

Objectives of Study:

To investigate the efficacy and safety of combined microsurgical and endovascular treatment in brain arteriovenous malformation compared with traditional microsurgery 

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)影像学证实为脑动脉瘤患者; (2)患者年龄12~60岁; (3)自愿参加临床试验并签署知情同意书,依从性良好的患者。 

Inclusion criteria

(1) a definitive diagnosis of brain aneurysm; (2) patient aged 12 to 60 years; (3) Signed an informed consent. 

排除标准:

(1)患者住院前已经接受过介入或放射治疗; (2)经急诊去骨瓣减压或颅内血肿清除术; (3)妊娠患者或患者正处于哺乳期; (4)有麻醉或手术相关禁忌症.或对造影剂过敏 

Exclusion criteria:

(1) patients initially undergoing endovascular or radiosurgery; (2) patients undergoing emergency removal of intracranial hematomas or decompressive craniectomy; (3) pregnancy and breastfeeding; (4) contraindications for general anesthesia or surgery, contraindications to performing digital substraction angiography. 

研究实施时间:

Study execute time:

From2019-04-16To 2020-12-31 

干预措施:

Interventions:

组别:

1

样本量:

80

Group:

1

Sample size:

干预措施:

显微手术联合介入治疗

干预措施代码:

Intervention:

combined surgery

Intervention code:

组别:

2

样本量:

80

Group:

2

Sample size:

干预措施:

显微手术

干预措施代码:

Intervention:

microsurgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学中南医院 

单位级别:

三甲 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

失血量

指标类型:

主要指标 

Outcome:

Loss of blood

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

operation time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改良Rankin评分

指标类型:

主要指标 

Outcome:

mRS scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

格拉斯哥昏迷评分

指标类型:

主要指标 

Outcome:

GCS scales

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

C-reaction protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血沉

指标类型:

主要指标 

Outcome:

ESR

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:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

脑脊液

组织:

Sample Name:

cerebrospinal fluid

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 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):

电脑随机数

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

Computer random number

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

试验完成后6个月内公开

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

Within six months after the trial complete

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:

2021年6月

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

June, 2021

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-16
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