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长期口服抗血小板药物的严重自发性脑出血病人的外科干预的效果和安全性评价研究
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注册号:

Registration number:

ChiCTR1900024406 

最近更新日期:

Date of Last Refreshed on:

2019-10-07 

注册时间:

Date of Registration:

2019-07-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

长期口服抗血小板药物的严重自发性脑出血病人的外科干预的效果和安全性评价研究 

Public title:

Effect and safety of surgical intervention for severe spontaneous intracerebral hemorrhage patients on long-term oral antiplatelet treatment 

注册题目简写:

ESSICHOAP 

English Acronym:

ESSICHOAP 

研究课题的正式科学名称:

长期口服抗血小板药物的严重自发性脑出血病人的外科干预的效果和安全性评价研究 

Scientific title:

Effect and safety of surgical intervention for severe spontaneous intracerebral hemorrhage patients on long-term oral antiplatelet treatment 

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:

吴俊 

研究负责人:

王硕 

Applicant:

Jun Wu 

Study leader:

Shuo Wang 

申请注册联系人电话:

Applicant telephone:

+86 13260457220 

研究负责人电话:

Study leader's telephone:

+86 13801180330 

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:

13260457220@163.com 

研究负责人电子邮件:

Study leader's E-mail:

captain9858@126.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:

北京市丰台区南四环西路119号 

研究负责人通讯地址:

北京市丰台区南四环西路119号 

Applicant address:

119 South Forth Ring Road West, Fengtai District, Beijing, China 

Study leader's address:

119 South Forth Ring Road West, Fengtai District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100070 

研究负责人邮政编码:

Study leader's postcode:

100070 

申请人所在单位:

首都医科大学附属北京天坛医院 

Applicant's institution:

Beijing Tiantan 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:

KY2019-096-02 

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:

首都医科大学附属北京天坛医院医学伦理委员会 

Name of the ethic committee:

IRB of Beijing Tiantan Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-02 

伦理委员会联系人:

任佩娟 

Contact Name of the ethic committee:

Peijuan Ren 

伦理委员会联系地址:

北京市丰台区南四环西路119号 

Contact Address of the ethic committee:

119 South Forth Ring Road West, Fengtai District, Beijing, 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:

首都医科大学附属北京天坛医院 

Primary sponsor:

Beijing Tiantan Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市丰台区南四环西路119号 

Primary sponsor's address:

119 South Forth Ring Road West, Fengtai District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京天坛医院

具体地址:

丰台区南四环西路119号

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University

Address:

119 South Forth Ring Road West, Fengtai District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京朝阳医院

具体地址:

朝阳区工人体育场南路8号

Institution
hospital:

Beijing Chaoyang Hospital, Capital Medical University

Address:

8 Workers Stadium Road South, Chaoyang District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院

具体地址:

西城区永安路95号

Institution
hospital:

Beijing Friendship Hospital, Capital Medical University

Address:

95 Yong'an Road, Xicheng District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京安贞医院

具体地址:

朝阳区安贞路2号

Institution
hospital:

Beijing Anzhen Hospital, Capital Medical University

Address:

2 Anzhen Road, Chaoyang District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市顺义区医院

具体地址:

顺义区光明南街3号

Institution
hospital:

Beijing Shunyi District Hospital

Address:

3 Guangming Street South, Shunyi District

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):

广州红十字会医院

具体地址:

海珠区同福中路396号

Institution
hospital:

Guangzhou Red Cross hospital

Address:

396 Middle Tongfu Road, Haizhu District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京平谷区医院

具体地址:

平谷区平谷镇新平北路59号

Institution
hospital:

Beijing Pinggu District Hospital

Address:

59 Xinping Road North, Pinggu Town, Pinggu District

经费或物资来源:

“十三五”计划重大专项 

Source(s) of funding:

Major special projects in the 13th five-year plan 

研究疾病:

严重自发性脑出血 

Target disease:

severe spontaneous intracerebral hemorrhage 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

基于6家区域性神经外科中心开展的sSICH-OAP病人的外科干预效果和安全性评价研究。对于sSICH-OAP病人,对比外科干预和保守治疗病人的死亡率和功能预后情况;对比分析有OAP病史和无OAP病史的sSICH病人的术后出血并发症情况;对于sSICH-OAP病人,影响术后出血并发症风险的危险因素;最终提出sSICH-OAP病人的手术干预时机和指征,建议该类病人的个体化手术风险评估体系。 

Objectives of Study:

We conduct this study based on six hospitals. The aim of this study is to : 1.compare the mortality and outcome of severe spontaneous intracerebral hemorrhage patients on oral antiplatelet medication treatment (sSCIH-OAP) treated by surgery and conservative care; 2.the difference of postoperative bleeding complication between patients on OAP and patients not on OAP; 3.investigate the risk factors related to postoperative bleeding complication in sSCIH-OAP paitents; finally establish the individual assessment of surgical risk for sSICH-OAP patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1 年龄在18-75岁; 2 非创伤性、自发性脑出血; 3 严重脑内出血(幕上出血量>30ml、幕下出血量>10ml、中线偏离> 1cm、或严重脑室内积血); 4 入院时GCS评分<13分; 5 签署知情同意书。 

Inclusion criteria

1 Aged 18-75 years; 2 Non-traumatic and spontaneous intracerebral hemorrhage; 3 Severe intracerebral hemorrhage (supratentorial bleeding volume >30ml, infratentorial bleeding volume >10ml, midline shift >1cm, or severe intraventricular hemorrhage); 4 Glasgow coma score (GCS) <13; 5 Sign informed consent. 

排除标准:

1 出血区域内有脑血管结构性病变或肿瘤(如颅内动脉瘤、脑血管畸形等),并且怀疑出血和这些病变相关; 2 出血型转化的缺血性脑卒中; 3 静脉栓塞导致的继发性出血; 4 由恶性肿瘤导致的凝血功能异常; 5 服用除抗血小板药物外的抗栓药物(维生素K拮抗剂(华法令)、新型抗凝药(达比加群、利伐沙班等)); 6 肝功能不全,ALT/AST>80U/L; 7 既往有血小板减少症病史,或凝血功能障碍疾病病史; 8 肾功能不全。 

Exclusion criteria:

1 Intracranial aneurysm, vascular malformation, or tumor associated with hemorrhage; 2 Hemorrhagic transformation of cerebral infarction; 3 Hemorrhage caused by venous thrombosis; 4 With coagulation dysfunction caused by malignant tumor; 5 Other anticoagulation (vitamin K antagonist (Warfarin), dabigatran and rivaroxaban); 6 Hypohepatia, ALT/AST >80U/L; 7 Thrombocytopenia or coagulation diseases; 8 Renal dysfunction. 

研究实施时间:

Study execute time:

From2019-08-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2019-08-01To 2022-06-01 

干预措施:

Interventions:

组别:

根据术后是否出血、有无 OAPT病史等因素分组

样本量:

180

Group:

Grouped by postoperative bleeding, the histrory of OAPT, etc..

Sample size:

干预措施:

外科手术

干预措施代码:

Intervention:

surgery

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):

首都医科大学附属北京天坛医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tiantan hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京朝阳医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Chaoyang hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京安贞医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Anzhen hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市顺义区医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Shunyi District hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

广州红十字会医院 

单位级别:

三级甲等 

Institution
hospital:

Guangzhou Red Cross hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京平谷区医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Pinggu District hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

总体死亡情况

指标类型:

主要指标 

Outcome:

total mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后出血并发症

指标类型:

次要指标 

Outcome:

postoperative intracranial bleeding

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

在院死亡情况

指标类型:

次要指标 

Outcome:

in-hospital mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能预后情况

指标类型:

次要指标 

Outcome:

function outcome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后主要心脑血管事件

指标类型:

次要指标 

Outcome:

postoperative major adverse cardiovascular/cerebral events

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:

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:

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 18 years
最大 Max age 75 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):

本研究为观察性研究,不涉及随机方法

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

This study is a observational study and doesn't involve Randomization Procedure.

盲法:

N/A

Blinding:

N/A

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

是Yes

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):

将以统计结果的形式在试验完成后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):

We will share statistical results 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:

本研究的所有病人信息均以CRF的形式保存

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

All patient information in this study was stored in the form of CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-10
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