今天是:2019-12-12 星期四

肝移植治疗慢加急性肝衰竭的临床和基础研究
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注册号:

Registration number:

ChiCTR1900021242 

最近更新日期:

Date of Last Refreshed on:

2019-02-03 

注册时间:

Date of Registration:

2019-02-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肝移植治疗慢加急性肝衰竭的临床和基础研究 

Public title:

The clinical and basic research for liver transplantation in acute-on-chronic liver failure 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

建立肝移植治疗乙肝相关慢加急性肝衰竭手术时机的预测评分系统 

Scientific title:

The predictive scoring system for the optimal timing of liver transplantation in hepatitis B-related acute-on-chronic liver failure 

研究课题代号(代码):

Study subject ID:

首都临床特色应用研究(Z181100001718143) 

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:

段斌炜 

研究负责人:

段斌炜 

Applicant:

Binwei Duan 

Study leader:

Binwei Duan 

申请注册联系人电话:

Applicant telephone:

+86 15801490896 

研究负责人电话:

Study leader's telephone:

+86 15801490896 

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:

bw_duan317@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

bw_duan317@aliyun.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:

北京市丰台区右安门外西头条8号 

研究负责人通讯地址:

北京市丰台区右安门外西头条8号 

Applicant address:

8 Toutiao Street West, You'anmen, Fengtai District, Beijing, China 

Study leader's address:

8 Toutiao Street West, You'anmen, Fengtai District, Beijing, 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:

首都医科大学附属北京佑安医院 

Applicant's institution:

Beijing You'an 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:

京佑科伦字[2019]012号 

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佑安医院伦理委员会 

Name of the ethic committee:

the Ethic Committee of Beijing Youan Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-09 

伦理委员会联系人:

孟莎 

Contact Name of the ethic committee:

Sha Meng 

伦理委员会联系地址:

北京丰台区右安门外西头条8号 

Contact Address of the ethic committee:

8 Toutiao Street West, You'anmen, 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佑安医院 

Primary sponsor:

Beijing Youan Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市丰台区右安门外西头条8号 

Primary sponsor's address:

8 Xitoutiao Street, You'anmen, Fengtai, 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佑安医院

具体地址:

右安门外西头条8号

Institution
hospital:

Beijing Youan Hospital, Capital Medical University

Address:

8 Toutiao Street West, You'anmen, Fengtai District

经费或物资来源:

首都临床特色应用研究(Z181100001718143) 

Source(s) of funding:

Capital Clinic Characteristics Application Research (Z181100001718143) 

研究疾病:

慢加急性肝衰竭 

Target disease:

Acute-on-chronic liver failure 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究拟通过单中心、前瞻性的临床对照研究,纳入诊断符合乙肝相关慢加急性肝衰竭的患者,按照治疗方式分为内科治疗组和肝移植治疗组,建立临床对照研究队列,研究终点为患者死亡。通过分析影响内科治疗组和肝移植治疗组患者的临床数据,发现影响两种治疗方式预后的重要因素,建立慢加急性肝衰竭患者预测评分系统,最终确定肝移植治疗乙肝相关慢加急性肝衰竭的最佳手术时机。 

Objectives of Study:

The patients with acute-on-chronic liver failure are enrolled to a single-center, prospectively, non-random clinical study and divided to two groups including medical treatment and liver transplantation according to the therapy model. The study end is death. The cinical data will be analyzed to find the factor influcing prognosis and set up a predicting score system of acute-on-chronic liver failure.The optimal timing for liver transplantation will be determined by a scoring system. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1. 年龄18-65周岁; 2. 既往有肝病史或肝硬化病史,包括入院时已明确诊断和既往没有诊断的肝病史,病因包括乙肝、丙肝、酒精性肝病、原发性硬化性胆管炎等肝病); 3. 自愿加入本临床研究。 

Inclusion criteria

1. Aged 18 to 65 years; 2. The patients with liver diseases and cirrhosis based on chronic hepatitis B/C,alcoholic liver disease and primary cirrhosis cholangitis,which were definitively diagnosed or not; 3. The subjects voluntarily join the study.  

排除标准:

1. 药物以及中毒等原因导致的急性肝衰竭,各种原因导致的慢性肝衰竭、失代偿期肝硬化; 2. 合并心脑肺等系统严重合并症。 

Exclusion criteria:

1. Acute liver failure induced by medicals and intoxation,chronic liver failure and decompensated cirrhosis; 2. With severe heart,brain and lung diseases. 

研究实施时间:

Study execute time:

From2019-02-11To 2021-07-31 

干预措施:

Interventions:

组别:

Group 1

样本量:

80

Group:

Group 1

Sample size:

干预措施:

内科治疗

干预措施代码:

Intervention:

Internal medicine treatment

Intervention code:

组别:

Group 2

样本量:

40

Group:

Group 2

Sample size:

干预措施:

肝移植

干预措施代码:

Intervention:

Liver transplantation

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 

市(区县):

丰台区 

Country:

China 

Province:

Beijing 

City:

Fengtai 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Youan Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

病死率

指标类型:

主要指标 

Outcome:

Mortality

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:

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 65 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):

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

none

盲法:

N/A

Blinding:

N/A

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):

2022 年3月 病历记录表

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

March 2022,CASE RECORD FORM

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:

病历记录表

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

CASE RECORD FORM

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-02-03
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