今天是:2019-03-25 星期一

急性前循环大血管闭塞血管内治疗早期联用尤瑞克林的前瞻性队列研究
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注册号:

Registration number:

ChiCTR1900020671 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

急性前循环大血管闭塞血管内治疗早期联用尤瑞克林的前瞻性队列研究 

Public title:

Prospective cohort study for early use of Urinary Kallidinogenase in the treatment of acute anterior circulation with large vessel occlusion 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

急性前循环大血管闭塞血管内治疗早期联用尤瑞克林的前瞻性队列研究 

Scientific title:

Prospective cohort study for early use of Urinary Kallidinogenase in the treatment of acute anterior circulation with large vessel occlusion 

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:

吴德平 

研究负责人:

吴德平 

Applicant:

Wu Deping 

Study leader:

Wu Deping 

申请注册联系人电话:

Applicant telephone:

+86 13952329182 

研究负责人电话:

Study leader's telephone:

+86 13952329182 

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:

wudeping520@139.com 

研究负责人电子邮件:

Study leader's E-mail:

wudeping520@139.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:

重庆市沙坪坝区新桥正街183号 

研究负责人通讯地址:

重庆市沙坪坝区新桥正街183号 

Applicant address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China 

Study leader's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400037 

研究负责人邮政编码:

Study leader's postcode:

400037 

申请人所在单位:

陆军军医大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Army Military Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

陆军军医大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Army Military Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区新桥正街183号 

Primary sponsor's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, 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):

重庆

市(区县):

沙坪坝区

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学第二附属医院

具体地址:

陆军军医大学第二附属医院

Institution
hospital:

The Second Affiliated Hospital of Army Medical University

Address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China

经费或物资来源:

陆军军医大学临床医学科研人才培养计划 

Source(s) of funding:

Army Military Medical University Clinical Medical Research Program 

研究疾病:

急性脑血管病 

Target disease:

Acute cerebrovascular diseases 

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:

上市后药物 

Study phase:

研究目的:

探讨发病24h内急性前循环大血管闭塞卒中患者,采用尤瑞克林联合血管内治疗与单纯血管内治疗相比的安全性和有效性。 

Objectives of Study:

To investigate the effectiveness and safety of using Urinary Kallidinogease for AIS with LVO considered for interventional treatment. 

药物成份或治疗方案详述:

本研究计划连续收集2019年01月到2021年12月全国48家卒中中心发病24小时内急性前循环大血管闭塞卒中患者,根据临床研究对象纳入标准和排除标准,纳入血管内治疗患者,按照患者接受治疗方式分为两组:试验组(尤瑞克林联合血管内治疗组)和对照组(血管内治疗组)。 

Description for medicine or protocol of treatment in detail:

The study plans to continuously collect patients with acute anterior circulation major vascular occlusion stroke within 48 hours from January 2019 to December 2021 in the country. According to the inclusion and exclusion criteria of the clinical study, patients were divided into two groups: the experimental group (Ulyklin combined with endovascular treatment group) and the control group (endovascular treatment group). 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1)年龄18周岁以上,性别不限; 2)发病时间在24小时以内; 3)急性缺血性卒中并经DSA确诊为合并前循环大血管闭塞,颈内动脉末端或大脑中动脉M1或M2段或大脑前动脉A1段完全性闭塞,并且NIHSS≥2分; 4)患者或家属签署临床用药知情同意书; 5)拟采用血管内血管内治疗。 

Inclusion criteria

1) Aged 18 years and older male and female; 2) The onset is ≤24 hours; 3) Patients with acute ischemic stroke and confirmed by DSA as anterior circulation vascular occlusion,complete internal occlusion of the internal carotid artery or middle cerebral artery M1 or M2 segment or anterior cerebral artery A1 segment,and NIHSSNIHSS ≥ 2 points; 4) The patient or family members sign the informed consent form for clinical medication; 5) Intravascular endovascular treatment is proposed. 

排除标准:

1)头颅计CT或MRI证实颅内出血; 2)昏迷; 3)神经功能迅速恢复正常; 4)癫痫; 5)妊娠或哺乳期妇女; 6)造影剂或镍钛合金试验过敏; 7)正参加其他临床试验; 8)收缩压>185 mmHg,或舒张压>110 mmHg,且口服降压药物无法控制; 9)遗传学或获得性出血体质,抗凝因子缺乏;或已口服抗凝药且INR>1.7; 10)血糖< 50 mg/dl (2.8 mmol/L)或> 400 mg/dl(22.2 mmol/L), 血小板<80*109/L, 或者红细胞压积<25%; 11)动脉迂曲致取栓装置无法到达目标血管; 12)近1个月有出血史; 13)颈动脉夹层、颈总动脉闭塞、动脉炎; 14)发病前mRS评分≥2分; 15)预期生存期<6个月; 16)血压≤90/60mmHg; 17)严重精神障碍者,包括痴呆; 18)对尤瑞克林过敏的患者; 19)患者及家属拒绝自费药物。 

Exclusion criteria:

1) Intracranial hemorrhage confirmed by CT or MRI; 2) Coma; 3) The nerve function quickly returns to normal; 4) Epilepsy; 5) Pregnant or lactating women; 6) Allergy to contrast agent or nickel-titanium alloy test; 7) are participating in other clinical trials; 8) Systolic blood pressure >185 mmHg, or diastolic blood pressure >110 mmHg, and oral antihypertensive drugs cannot be controlled; 9) Genetic or acquired hemorrhagic constitution, lack of anticoagulant factor; or oral anticoagulant and INR > 1.7; 10) Blood glucose < 50 mg/dl (2.8 mmol/L) or>400 mg dl (22.2 mmol/L), platelets <80 * 109/L, or hematocrit < 25%; 11) The arterial tortuosity device can not reach the target blood vessel; 12) A history of bleeding in the past 1 month; 13) Carotid artery dissection, common carotid artery occlusion, arteritis; 14) mRS score ≥ 2 points before onset; 15) Expected survival period <6 months; 16) Blood pressure ≤ 90/60mmHg; 17) People with severe mental disorders, including dementia; 18) Patients who are allergic to Ureklin; 19) Patients and their families refused to pay for their own drugs. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

单纯血管内治疗组

样本量:

189

Group:

Case series

Sample size:

干预措施:

血管内治疗

干预措施代码:

Intervention:

endovascular treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

沙坪坝区 

Country:

China 

Province:

Congqing 

City:

 

单位(医院):

陆军军医大学第二附属医院 

单位级别:

三甲医院 

Institution
hospital:

Xinqiao Hospital, the Army Military Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

蚌埠 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

解放军第123医院 

单位级别:

三甲 

Institution
hospital:

The 123th Hospital of the PLA  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽省立医院 

单位级别:

三甲 

Institution
hospital:

Anhui Provincial Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

六安 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽医科大学附属六安医院 

单位级别:

三甲 

Institution
hospital:

Luan Affiliated Hospital of Anhui Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

解放军福州总医院 

单位级别:

三甲 

Institution
hospital:

Fuzhou General Hospital of the PLA  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

漳州 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

解放军第175医院 

单位级别:

三甲 

Institution
hospital:

The 175th Hospital of the PLA  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省人民医院 

单位级别:

三甲 

Institution
hospital:

Guangdong General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州医科大学第三附属医院 

单位级别:

三甲 

Institution
hospital:

The Third Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

90天mRS评分

指标类型:

主要指标 

Outcome:

mRS score at 90 days

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

48小时内症状性颅内出血发生率

指标类型:

主要指标 

Outcome:

Symptomatic intracerebral hemorrhage rate within 48 h

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

早期神经功能缺损

指标类型:

次要指标 

Outcome:

Early Neurological Deterioration

Type:

Secondary indicator 

测量时间点:

48小时

测量方法:

NIHSS评分

Measure time point of outcome:

within 48 h

Measure method:

NIHSS score

指标中文名:

梗死灶体积

指标类型:

次要指标 

Outcome:

Infarct volume

Type:

Secondary indicator 

测量时间点:

4-7天

测量方法:

CT/MRI

Measure time point of outcome:

within 4 to 7 days

Measure method:

CT/MRI

指标中文名:

90天神经功能改善程度

指标类型:

次要指标 

Outcome:

90 days of neurological improvement

Type:

Secondary indicator 

测量时间点:

90天

测量方法:

NIHSS 评分

Measure time point of outcome:

90th days

Measure method:

NIHSS score

指标中文名:

非颅内出血并发症

指标类型:

次要指标 

Outcome:

Non-intracranial hemorrhagic complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非出血性严重不良事件发生率

指标类型:

次要指标 

Outcome:

Non-hemorrhagic serious adverse events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

操作及器械相关并发症

指标类型:

次要指标 

Outcome:

Operational and device related complications

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

观察性研究,无需随化

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

Prospective study need not randomization.

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):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

相关论文发表5年后在Resman平台公开原始数据

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

Related papers published five years later, the IPD will be shared on ResMan.

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:

采用病例报告表(CRF)和临床试验电子数据采集系统(EDC)ResMan采集与管理数据

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

Use Case Record Form (CRF) and Electronic Data Capture (EDC), ResMan to collect and manage data.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-12
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