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血浆渗透压与动脉瘤破裂蛛网膜下腔出血预后的相关性分析
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注册号:

Registration number:

ChiCTR2000040019 

最近更新日期:

Date of Last Refreshed on:

2021-01-03 

注册时间:

Date of Registration:

2020-11-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血浆渗透压与动脉瘤破裂蛛网膜下腔出血预后的相关性分析 

Public title:

Analysis of the relationship between plasma osmotic pressure and prognosis of subarachnoid hemorrhage after ruptured aneurysm 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血浆渗透压与动脉瘤破裂蛛网膜下腔出血预后的相关性分析 

Scientific title:

Analysis of the relationship between plasma osmotic pressure and prognosis of subarachnoid hemorrhage after ruptured aneurysm 

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:

翟傲 

研究负责人:

燕宪亮 

Applicant:

Zhai Ao 

Study leader:

Yan Xianliang 

申请注册联系人电话:

Applicant telephone:

+86 15005217778 

研究负责人电话:

Study leader's telephone:

+86 18052238393 

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:

1246772965@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

docyxl@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:

江苏省徐州市淮海西路99号 

研究负责人通讯地址:

江苏省徐州市淮海西路99号 

Applicant address:

99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, China 

Study leader's address:

99 Huaihai Road West, Xuzhou, Jiangsu, 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:

徐州医科大学附属医院急诊科 

Applicant's institution:

Emergency Department of affiliated Hospital of Xuzhou 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:

XYFY2020-KL144-01 

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:

徐州医科大学附属医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the affiliated Hospital of Xuzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-30 

伦理委员会联系人:

许铁 

Contact Name of the ethic committee:

Xu Tie 

伦理委员会联系地址:

江苏省徐州市淮海西路99号 

Contact Address of the ethic committee:

99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, 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:

徐州医科大学附属医院急诊科 

Primary sponsor:

Emergency Department of affiliated Hospital of Xuzhou Medical University 

研究实施负责(组长)单位地址:

江苏省徐州市淮海西路99号 

Primary sponsor's address:

99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, 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):

江苏省

市(区县):

徐州市

Country:

China

Province:

Jiangsu

City:

单位(医院):

徐州医科大学附属医院

具体地址:

徐州市淮海西路99号

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University

Address:

99 Huaihai Road West, Quanshan District, Xuzhou

经费或物资来源:

徐州医科大学附属医院急诊科 

Source(s) of funding:

Emergency Department of affiliated Hospital of Xuzhou Medical University 

研究疾病:

动脉瘤破裂自发性蛛网膜下腔出血 

Target disease:

Spontaneous subarachnoid hemorrhage of ruptured aneurysm 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

血浆渗透压与动脉瘤破裂蛛网膜下腔出血预后的相关性分析 

Objectives of Study:

Analysis of the relationship between plasma osmotic pressure and prognosis of subarachnoid hemorrhage after ruptured aneurysm 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)经头颅CT证实为蛛网膜下腔出血,经头颅CTA证实为动脉瘤破裂引起的出血。其余诊断均符合蛛网膜下腔出血患者诊断标准; (2)均为首次发病; (3)均有完整无遗漏临床资料,包括入院首次进行检查的血糖、血钠离子、血清尿素氮、白蛋白等血清学指标。 

Inclusion criteria

(1) subarachnoid hemorrhage was confirmed by cranial CT, and hemorrhage caused by ruptured aneurysm was confirmed by cranial CTA. The other diagnoses were in accordance with the diagnostic criteria of patients with subarachnoid hemorrhage; (2) they all occurred for the first time; (3) there were complete clinical data without omission, including blood glucose, serum sodium ion, serum urea nitrogen, albumin and other serological indexes. 

排除标准:

(1)其他原因引起的蛛网膜下腔出血,如:头部外伤引起蛛网膜下腔出血、非动脉瘤性中脑周围出血、脑动静脉畸形、脑底异常血管网病、硬脑膜动静脉瘘、夹层动脉瘤、颅内肿瘤、血液病、正接受抗凝治疗等; (2)入院时已有电解质紊乱、活动性感染及自身免疫性疾病患者。 (3)随访过程中失联的患者。 

Exclusion criteria:

(1) subarachnoid hemorrhage caused by other causes, for example: subarachnoid hemorrhage caused by head trauma, non-aneurysmal midbrain hemorrhage, cerebral arteriovenous malformations, abnormal vascular network disease of the brain floor, dural arteriovenous fistula, dissecting aneurysms, intracranial tumors, hematopathy, anticoagulation therapy, etc.; (2) patients with electrolyte disorders, active infections and autoimmune diseases were admitted to hospital; (3) the patients who were lost during the follow-up. 

研究实施时间:

Study execute time:

From2020-11-20To 2020-12-17 

征募观察对象时间:

Recruiting time:

From2020-11-20To 2020-12-17 

干预措施:

Interventions:

组别:

2

样本量:

94

Group:

two

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

no intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

徐州医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血浆渗透压

指标类型:

主要指标 

Outcome:

Plasma osmotic pressure

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:

血浆

组织:

Sample Name:

Plasma

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 87 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):

无随机分组

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

no Randomization Procedure

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

通过发表论文

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

By publishing a paper

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:

CRF+EDC

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

CRF+EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-18
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