今天是:2019-01-21 星期一

“脑-血肿”压力差对高血压脑出血手术过程及效果的影响
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注册号:

Registration number:

ChiCTR1900020655 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

“脑-血肿”压力差对高血压脑出血手术过程及效果的影响 

Public title:

Rules regarding the ‘brain-hematoma’ pressure gradient in hypertensive cerebral hemorrhage: Comparisons and observations 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

“脑-血肿”压力差对高血压脑出血手术过程及效果的影响 

Scientific title:

Rules regarding the ‘brain-hematoma’ pressure gradient in hypertensive cerebral hemorrhage: Comparisons and observations 

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:

孙国庆 

研究负责人:

孙国庆 

Applicant:

Guoqing Sun 

Study leader:

Guoqing Sun 

申请注册联系人电话:

Applicant telephone:

+86 13863338028 

研究负责人电话:

Study leader's telephone:

+86 13863338028 

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:

13863338028@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13863338028@163.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:

山东省日照市东港区泰安路126号 

研究负责人通讯地址:

山东省日照市日照市人民医院神经外一科 

Applicant address:

126 Tai'an Road, Donggang District, Rizhao, Shandong, China 

Study leader's address:

Department of Neurosurgery, Rizhao People's Hospital, Rizhao, Shandong 

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:

山东省日照市人民医院神经外一科 

Applicant's institution:

Neurosurgery Depatment, Rizhao People's Hospital 

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:

20181002 

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:

日照市人民医院伦理委员会 

Name of the ethic committee:

The IEC of Rizhao People’s Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-01 

伦理委员会联系人:

郑加平 

Contact Name of the ethic committee:

JiaPing Zheng 

伦理委员会联系地址:

山东省日照市日照市人民医院 

Contact Address of the ethic committee:

Rizhao People's Hospital, Rizhao, Shandong 

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:

日照市人民医院 

Primary sponsor:

Rizhao People's Hospital 

研究实施负责(组长)单位地址:

山东省日照市东港区泰安路126号 

Primary sponsor's address:

126 Tai'an Road, Donggang District, Rizhao, Shandong, 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):

山东

市(区县):

日照

Country:

china

Province:

Shandong

City:

单位(医院):

日照市人民医院

具体地址:

日照市东港区泰安路126号

Institution
hospital:

Rizhao People's Hospital

Address:

126 Tai'an Road, Donggang District, Rizhao, Shandong, China

经费或物资来源:

济宁医学院教师扶持基金 

Source(s) of funding:

Jining Medical University teacher support fund 

研究疾病:

脑出血 

Target disease:

hypertensive cerebral hemorrhage 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过对比研究高血压脑出血不同手术方式术中“脑-血肿”压力差的大小及变化方式,分析其对手术过程及效果的影响。 

Objectives of Study:

To comparatively study the size and variation of brain-hematoma pressure difference in different surgical methods for hypertensive cerebral hemorrhage, and analyse its influence on the surgical procedure and effects. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

半随机对照 

Study design:

Quasi-randomized controlled 

纳入标准:

诊断高血压脑出血,血肿位于幕上且量大于30ml。 

Inclusion criteria

Patients diagnosed as hypertensive intracerebral hemorrhage with hematoma located on the screen and the volume of hematoma was greater than 30ml.  

排除标准:

1.排除颅内动脉瘤、颅内动静脉畸形或肿瘤等其他原因导致的出血; 2.排除脑疝病人。 

Exclusion criteria:

1. Patients with cerebral hemorrhage that are caused by intracranial aneurysm, intracranial arteriovenous malformation, tumors and other reasons were excludedso; 2. Patients with cerebral hernia.  

研究实施时间:

Study execute time:

From2019-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

Group 1

样本量:

36

Group:

Group 1

Sample size:

干预措施:

锁孔内镜组

干预措施代码:

Intervention:

Clavicular endoscopy group

Intervention code:

组别:

Group 2

样本量:

36

Group:

Group 2

Sample size:

干预措施:

大骨瓣开颅组

干预措施代码:

Intervention:

large bone flap craniotomy group

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

日照 

Country:

china 

Province:

shandong 

City:

rizhao 

单位(医院):

日照市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Rizhao People’s Hospital  

Level of the institution:

Three class A 

测量指标:

Outcomes:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

Operative 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:

术中出血量

指标类型:

主要指标 

Outcome:

Intraoperative bleeding volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血量

指标类型:

主要指标 

Outcome:

Transfusion volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肿清除率

指标类型:

主要指标 

Outcome:

Average hematoma clearance rate (%)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

主要指标 

Outcome:

Mortality rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

再出血率

指标类型:

主要指标 

Outcome:

Rebleeding rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重度水肿率

指标类型:

主要指标 

Outcome:

Rate of severe edema

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ADL康复评分

指标类型:

主要指标 

Outcome:

Good rate of postoperative ADL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颅内压

指标类型:

主要指标 

Outcome:

mean ICP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肿压

指标类型:

主要指标 

Outcome:

Hematoma pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑-血肿压力差

指标类型:

主要指标 

Outcome:

‘brain-hematoma’ pressure gradient

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 30 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):

根据入院时间顺序,由治疗医生随机选择手术方式 (错误的随机方法)

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

According to the time sequence of admission, the surgeon randomly selected the operation method.

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):

通过电子邮件向研究者申请共享,13863338028@163.com

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

Apply to researchers for sharing via e-mail, 13863338028@163.com

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-11
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