Large vessel thrombosis in patients with COVID-19

注册号:

Registration number:

ChiCTR2000038537 

最近更新日期:

Date of Last Refreshed on:

2020-09-23 05:26:10 

注册时间:

Date of Registration:

2020-09-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

Large vessel thrombosis in patients with COVID-19

Public title:

Large vessel thrombosis in patients with COVID-19

注册题目简写:

English Acronym:

研究课题的正式科学名称:

A single center prospective case series study of large vessel thrombosis due to COVID-19

Scientific title:

A single center prospective case series study of large vessel thrombosis due to COVID-19

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:

Hawbash Mohammed-Amin Rahim 

研究负责人:

Fahmi Hussein Kakamad 

Applicant:

Hawbash Mohammed-Amin Rahim 

Study leader:

Fahmi Hussein Kakamad 

申请注册联系人电话:

Applicant telephone:

+96 475 03282480

研究负责人电话:

Study leader's
telephone:

+96 477 25268326

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:

hawbash.mhamad@kscien.org

研究负责人电子邮件:

Study leader's E-mail:

fahmi.hussein@univsul.edu.iq

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:

Hawari Shar Str, Sulaimani, Kurdistan, Iraq

研究负责人通讯地址:

Shari Pzishkan, Sulaimani, Kurdistan, Iraq

Applicant address:

Hawari Shar Str, Sulaimani, Kurdistan, Iraq

Study leader's address:

Shari Pzishkan, Sulaimani, Kurdistan, Iraq

申请注册联系人邮政编码:

Applicant postcode:

46000

研究负责人邮政编码:

Study leader's postcode:

46000

申请人所在单位:

伊拉克苏莱曼尼大学

Applicant's institution:

Kscien Organization for Scientific Research

研究负责人所在单位:

伊拉克苏莱曼尼大学

Affiliation of the Leader:

Sulaimani University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

125

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:

伊拉克苏莱曼尼大学

Name of the ethic committee:

University of Sulaimani

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-01 00:00:00

伦理委员会联系人:

Hawbash Mohammed Amin

Contact Name of the ethic committee:

Hawbash Mohammed Amin

伦理委员会联系地址:

Mala Dawd

Contact Address of the ethic committee:

Mala Dawd

伦理委员会联系人电话:

Contact phone of the ethic committee:

+96 475 03282480

伦理委员会联系人邮箱:

Contact email of the ethic committee:

hawbash.mhamad@kscien.org

研究实施负责(组长)单位:

伊拉克苏莱曼尼大学

Primary sponsor:

University of Sulaimani

研究实施负责(组长)单位地址:

François Mitterrand Street

Primary sponsor's address:

François Mitterrand Street

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

伊拉克

省(直辖市):

苏莱曼尼亚

市(区县):

苏莱曼尼

Country:

Iraq

Province:

Sulaymaniyah

City:

Sulaimani

单位(医院):

苏莱曼尼大学

具体地址:

苏莱曼尼大学

Institution
hospital:

Sulaimani University

Address:

Sulaimani University, Old Campus

经费或物资来源:

Smart health tower

Source(s) of funding:

Smart health tower

研究疾病:

新型冠状病毒肺炎(COVID-19)  

Target disease:

Novel Coronavirus Pneumonia (COVID-19)

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

研究设计:

病例研究 

Study design:

Case study 

研究目的:

The aim of this study to present a series of cases with large vessel thrombosis due to COVID-19.  

Objectives of Study:

The aim of this study to present a series of cases with large vessel thrombosis due to COVID-19.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

(1) Any patient without COVID-19;
(2) COVID patients without major vessel thrombois;
(3) Patient with less than 2 month follow up.

Exclusion criteria:

(1) Any patient without COVID-19;
(2) COVID patients without major vessel thrombois;
(3) Patient with less than 2 month follow up.

研究实施时间:

Study execute time:

From 2020-01-01 00:00:00 To 2020-08-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2020-02-01 00:00:00 To 2020-03-01 00:00:00

干预措施:

Interventions:

组别:

Cases

样本量:

7

Group:

Cases

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

伊拉克

省(直辖市):

苏莱曼尼 

市(区县):

苏莱曼尼 

Country:

Iraq

Province:

Sulaimani

City:

Sulaimani

单位(医院):

苏莱曼尼大学 

单位级别:

大学 

Institution
hospital:

Sulaimani University

Level of the institution:

Sulaimani University, Old Campus

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标

Outcome:

None

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:

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

No

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

None

Blinding:

None

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):

None

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

None

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:

the data collection was performed using an excel sheet, they were transferred to the Statistical Package for the Social Sciences (SPSS) software, version 22 after coding. Due to the small sample size, only descriptive analysis was calculated.

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

the data collection was performed using an excel sheet, they were transferred to the Statistical Package for the Social Sciences (SPSS) software, version 22 after coding. Due to the small sample size, only descriptive analysis was calculated.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-09-23 05:26:10