ChiCTR2100044537 版本V1.0 版本创建时间2021/09/18 14:14:44 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100044537 

最近更新日期：

Date of Last Refreshed on：

 2021-03-23 05:26:44 

注册时间：

Date of Registration：

 2021-03-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

SHOCK INDEX AS A PROGNOSTICATOR FOR EMERGENT SURGICAL INTERVENTION AND MORTALITY IN TRAUMA PATIENTS AT A TERTIARY HOSPITAL IN JOHANNESBURG: A MEDICAL RECORDS BASED RETROSPECTIVE COHORT REVIEW

Public title：

SHOCK INDEX AS A PROGNOSTICATOR FOR EMERGENT SURGICAL INTERVENTION AND MORTALITY IN TRAUMA PATIENTS AT A TERTIARY HOSPITAL IN JOHANNESBURG: A MEDICAL RECORDS BASED RETROSPECTIVE COHORT REVIEW

注册题目简写：

English Acronym：

研究课题的正式科学名称：

SHOCK INDEX AS A PROGNOSTICATOR FOR EMERGENT SURGICAL INTERVENTION AND MORTALITY IN TRAUMA PATIENTS AT A TERTIARY HOSPITAL IN JOHANNESBURG: A MEDICAL RECORDS BASED RETROSPECTIVE COHORT REVIEW

Scientific title：

SHOCK INDEX AS A PROGNOSTICATOR FOR EMERGENT SURGICAL INTERVENTION AND MORTALITY IN TRAUMA PATIENTS AT A TERTIARY HOSPITAL IN JOHANNESBURG: A RETROSPECTIVE COHORT REVIEW

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：

Dr Richard Allan Crawford 

研究负责人：

Dr Richard Allan Crawford 

Applicant：

Dr Richard Allan Crawford 

Study leader：

Dr Richard Allan Crawford 

申请注册联系人电话：

Applicant telephone：

 +27 8 28461559

研究负责人电话：

Study leader's
telephone：

+27 8 28461559

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：

 rcrawford.sa@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 rcrawford.sa@gmail.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：

160 Ag De Witt Dr Solheim, Johannesburg, South Africa

研究负责人通讯地址：

160 Ag De Witt Dr Solheim, Johannesburg, South Africa

Applicant address：

160 Ag De Witt Dr Solheim, Johannesburg, South Africa

Study leader's address：

160 Ag De Witt Dr Solheim, Johannesburg, South Africa

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：

南非约翰内斯堡University of Witwatersrand

Applicant's institution：

The University of the Witwatersrand

研究负责人所在单位：

南非约翰内斯堡University of Witwatersrand

Affiliation of the Leader：

The University of the Witwatersrand

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：

 M190814

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：

The University of the Witwatersrand Human Research Ethics Committee (Medical)

Name of the ethic committee：

The University of the Witwatersrand Human Research Ethics Committee (Medical)

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-11-08 00:00:00

伦理委员会联系人：

Zanele Ndlovu

Contact Name of the ethic committee：

Zanele Ndlovu

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：

 +27 1 17172700

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 zanele.ndlovu@wits.ac.za

研究实施负责（组长）单位：

Dr Richard Allan Crawford

Primary sponsor：

Dr Richard Allan Crawford

研究实施负责（组长）单位地址：

129 The Meridian, 160 Ag De Witt Dr Solheim, Johannesburg, South Africa

Primary sponsor's address：

129 The Meridian, 160 Ag De Witt Dr Solheim, Johannesburg, South Africa

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

南非

省(直辖市)：

Gauteng

市(区县)：

Parktown

Country：

South Africa

Province：

Gauteng

City：

Parktown

单位(医院)：

The University of the Witwatersrand

具体地址：

7 York Road Parktown

Institution
hospital：

The University of the Witwatersrand

Address：

7 York Road Parktown

经费或物资来源：

Private

Source(s) of funding：

Private

研究疾病：

Trauma  

Target disease：

Trauma

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

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

To describe the demographics (Age, Gender, Population group) of patients presenting to the Trauma Unit. To describe the mechanism of injury (blunt/penetrating) of patients presenting to the Trauma Unit and their relationship to SI. To describe the distribution of anatomical regions and initial physiological parameters of injuries in terms of Injury Severity scores. To evaluate the relationship between the SI and need for emergent surgical intervention To describe the type of emergent surgical intervention performed. To describe the relationship between SI and in-hospital mortality.  

Objectives of Study：

To describe the demographics (Age, Gender, Population group) of patients presenting to the Trauma Unit. To describe the mechanism of injury (blunt/penetrating) of patients presenting to the Trauma Unit and their relationship to SI. To describe the distribution of anatomical regions and initial physiological parameters of injuries in terms of Injury Severity scores. To evaluate the relationship between the SI and need for emergent surgical intervention To describe the type of emergent surgical intervention performed. To describe the relationship between SI and in-hospital mortality.

药物成份或治疗方案详述：

Not Applicable 

Description for medicine or protocol of treatment in detail：

Not Applicable 

纳入标准：

All records of patients over the age of 18 years old who were trauma team activations

Inclusion criteria

All records of patients over the age of 18 years old who were trauma team activations

排除标准：

Patients declared Dead on Arrival or whose injuries are deemed non-survivable;
All isolated Traumatic Brain Injury (TBI) patients and Isolated Thermal/Chemical Injuries;
All patients taken for surgery for isolated Orthopaedic procedures where by the procedure is not related to the control of haemorrhage;
Patients whose physiological response to hypovolemia will be altered such as those known to be on rate control medications / pace makers or started on inotropes prior to hospital admission;
Patients referred in from another hospital;
Patients discharged / who sign refusal of hospital treatment or abscond without admission to the unit for further treatment.

Exclusion criteria：

Patients declared Dead on Arrival or whose injuries are deemed non-survivable;
All isolated Traumatic Brain Injury (TBI) patients and Isolated Thermal/Chemical Injuries;
All patients taken for surgery for isolated Orthopaedic procedures where by the procedure is not related to the control of haemorrhage;
Patients whose physiological response to hypovolemia will be altered such as those known to be on rate control medications / pace makers or started on inotropes prior to hospital admission;
Patients referred in from another hospital;
Patients discharged / who sign refusal of hospital treatment or abscond without admission to the unit for further treatment.

研究实施时间：

Study execute time：

从 From 2018-11-01 00:00:00至 To 2021-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-01-01 00:00:00 至 To 2019-12-31 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 1523

Group：

Case series

Sample size：

干预措施：

Emergency surgical Intervention

干预措施代码：

Intervention：

Emergency surgical Intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 南非

省(直辖市)：

 Gauteng 

市(区县)：

 Parktown 

Country：

South Africa

Province：

Gauteng

City：

Parktown

单位(医院)：

 The University of the Witwatersrand, arlotte Maxeke Academic Hospital Johannesburg (CMJAH) Trauma Unit 

单位级别：

 三级 

Institution
hospital：

The University of the Witwatersrand, arlotte Maxeke Academic Hospital Johannesburg (CMJAH) Trauma Unit

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Survival

指标类型：

主要指标

Outcome：

Survival

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：

No

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 岁 years
最大 Max age 88 岁 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）：

N/A

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

Not Applicable - Retrospective record review

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

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）：

Application to The University of the Witwatersrand HREC

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

Application to The University of the Witwatersrand HREC

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：

Medibank Trauma Form

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

Medibank Trauma Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-03-23 05:26:44