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术中回收式自体输血应用于出血高危剖宫产手术的前瞻性随机对照多中心临床研究
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注册号:

Registration number:

ChiCTR-ICC-15007096 

最近更新日期:

Date of Last Refreshed on:

2015-09-18 

注册时间:

Date of Registration:

2015-09-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

术中回收式自体输血应用于出血高危剖宫产手术的前瞻性随机对照多中心临床研究 

Public title:

Intraoperative cell salvage in high bleeding risk cesarean section: A prospective randomized controlled multi-center clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术中回收式自体输血应用于出血高危剖宫产手术的前瞻性随机对照多中心临床研究 

Scientific title:

Intraoperative cell salvage in high bleeding risk cesarean section: A prospective randomized controlled multi-center clinical trial 

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:

卫新 

研究负责人:

张卫 

Applicant:

Wei Xin 

Study leader:

Zhang Wei 

申请注册联系人电话:

Applicant telephone:

+86 15003995323 

研究负责人电话:

Study leader's telephone:

+86 13673996966 

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:

787611423@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangw571012@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:

郑州市建设东路1号 

研究负责人通讯地址:

郑州市建设东路1号 

Applicant address:

1 East Jianshe Road, Zhengzhou 

Study leader's address:

1 East Jianshe Road, Zhengzhou 

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:

郑州大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Zhengzhou 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:

2015-9 

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:

郑州大学第一附属医院医学科研伦理委员会 

Name of the ethic committee:

Ethics committee of the First Affiliated Hospital of Zhengzhou University 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-04-16 

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:

郑州大学第一附属医院麻醉科 

Primary sponsor:

Department of Anesthesiology of the First Affiliated Hospital of Zhengzhou University 

研究实施负责(组长)单位地址:

郑州市建设东路1号 

Primary sponsor's address:

1 East Jianshe Road, Zhengzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

省部共建项目 

Source(s) of funding:

Provincial andministerial project 

研究疾病:

出血高危剖宫产 

Target disease:

high bleeding risk cesarean section 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评估手术中应用回收式自体输血技术是否能减少大量出血剖宫产患者围术期同种异体输血量。 评估与同种异体输血相比,术中回收式自体输血是否减少高危剖宫产产妇术后死亡率和并发症发生率。 

Objectives of Study:

To evaluate whether intraoperative cell salvage in high bleeding risk cesarean section could reduce allogeneic blood transfusion andcompared with allogeneic blood transfusion whether could reduce postoperative mortality andmorbidity. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1)年龄 ≥ 18岁 2)择期或急诊剖宫产手术患者 3)美国麻醉医师协会(ASA)分级I~II级 4)预计术中出血量可能超过1000 mL者 

Inclusion criteria

1. >=18 years; 2. caesarean section; 3. ASA physical status classification I~II; 4. expected blood loss>=1000ml. 

排除标准:

1)术前Hb < 9 g/dL 2)术前血小板 < 50×109/L 3)术前PT、APTT较正常值延长1.5倍以上 4)合并血液系统疾病 5)术前接受过抗凝治疗 6)体重小于45kg 7)合并自身免疫性疾病/急性脂肪肝/HELLP综合征 8)在入选研究前的3个月内接受过同种异体输血 9)患者拒绝接受同种异体输血 10)在妊娠期间参与了其他临床研究 11)任何导致不能配合研究的原因,例如:精神疾病、语言理解障碍等 

Exclusion criteria:

1. Preoperative Hb <9 g/dL; 2. Preoperative PLT < 50*10^9/L; 3. Preoperative PTAPTT > 1.5 times normal value; 4. With hematological diseases; 5. Preoperative anticoagulant therapy; 6. Weight < 45kg; 7. Wiith autoimmune disease / acute fatty liver /HELLP syndrome; 8. Received allogeneic blood transfusion in 3 months before the study; 9. Refuse allogeneic blood transfusion; 10. Participated in other clinical research during pregnancy; 11. Any cause that can not comply with the study including mental illness, etc. 

研究实施时间:

Study execute time:

From2015-11-01To  

征募观察对象时间:

Recruiting time:

From2015-11-01To  

干预措施:

Interventions:

组别:

回收式自体输血组

样本量:

550

Group:

ICS group

Sample size:

干预措施:

回收式自体输血

干预措施代码:

Intervention:

intraoperative cell salvage

Intervention code:

组别:

同种异体输血组

样本量:

550

Group:

ABT group

Sample size:

干预措施:

异体输血

干预措施代码:

Intervention:

Allogeneic blood transfusion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

the First Affiliated Hospital of Zhengzhou University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

异体输血量

指标类型:

主要指标 

Outcome:

volume of allogeneic blood transfusion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率和并发症发生率

指标类型:

主要指标 

Outcome:

morbidity andmortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白

指标类型:

次要指标 

Outcome:

hemoglobin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能

指标类型:

次要指标 

Outcome:

coagulation function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后谵妄

指标类型:

次要指标 

Outcome:

postoperative delirium

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU入住情况

指标类型:

次要指标 

Outcome:

ICU stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院日和费用

指标类型:

次要指标 

Outcome:

hospital stay andcost

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 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由统计员使用计算机软件产生随机序列

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

Random sequence by statisticians using computer software

盲法:

Blinding:

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

否No

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):

郑州大学第一附属医院麻醉科

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

Department of Anesthesiology of the First Affiliated Hospital of Zhengzhou University

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:

郑州大学第一附属医院麻醉科

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

Department of Anesthesiology of the First Affiliated Hospital of Zhengzhou University

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-09-18
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