ChiCTR2300071951 版本V1.1 版本创建时间2023/07/23 11:21:56 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：

 ChiCTR2300071951 

最近更新日期：

Date of Last Refreshed on：

 2023-05-30 11:28:58 

注册时间：

Date of Registration：

 2023-05-30 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Please fill in the data management platform. Impact of intravenous iron therapy on outcomes and exercise performance in cardiac surgical patients

Public title：

Impact of intravenous iron therapy on outcomes and exercise performance in cardiac surgical patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Impact of treating iron deficiency with intravenous iron therapy during prehabilitation period on outcomes and exercise performance in cardiac surgical patients

Scientific title：

Impact of treating iron deficiency with intravenous iron therapy during prehabilitation period on outcomes and exercise performance in cardiac surgical patients

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：

King Wai YAU 

研究负责人：

King Wai YAU 

Applicant：

King Wai YAU 

Study leader：

King Wai YAU 

申请注册联系人电话：

Applicant telephone：

 +852 3505 1912

研究负责人电话：

Study leader's
telephone：

+852 3505 1912

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：

 derekyaukw@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 derekyaukw@link.cuhk.edu.hk

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：

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong

研究负责人通讯地址：

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong

Applicant address：

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong

Study leader's address：

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong

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：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Applicant's institution：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

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：

 2018.140

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：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-06-20 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

Joint CUHK-NTEC Clinical Research Ethics Committee, 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Sha Tin, Hong Kong

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee, 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Sha Tin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Primary sponsor：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, N.T., Hong Kong

Primary sponsor's address：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, N.T., Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Hong Kong

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong

单位(医院)：

The Chinese University of Hong Kong

具体地址：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, N.T., Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, N.T., Hong Kong

经费或物资来源：

Internal funding of the department

Source(s) of funding：

Internal funding of the department

研究疾病：

Cardiovascular disease  

Target disease：

Cardiovascular disease

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：

队列研究 

Study design：

Cohort study 

研究目的：

The objectives of this study are to: 1. Determine the preoperative and postoperative prevalences of anaemia and iron deficiency 2. Assess the impact of single dose intravenous iron isomaltoside (20mg/kg for body weight<50kg, 1000mg for body weight>50kg), given 3-10 weeks before elective cardiac surgery, on postoperative outcomes up to 30 days after surgery. 3. Evaluate the impact of single dose intravenous iron isomaltoside (20mg/kg for body weight<50kg, 1000 mg for body weight>50kg), given 3-10 weeks before elective cardiac surgery, on exercise tolerance and performance up to 30 days after surgery 4. Determine the safety profile of intravenous iron isomaltoside and its effect on preoperative and postoperative haemoglobin and ferritin concentrations.  

Objectives of Study：

The objectives of this study are to: 1. Determine the preoperative and postoperative prevalences of anaemia and iron deficiency 2. Assess the impact of single dose intravenous iron isomaltoside (20mg/kg for body weight<50kg, 1000mg for body weight>50kg), given 3-10 weeks before elective cardiac surgery, on postoperative outcomes up to 30 days after surgery. 3. Evaluate the impact of single dose intravenous iron isomaltoside (20mg/kg for body weight<50kg, 1000 mg for body weight>50kg), given 3-10 weeks before elective cardiac surgery, on exercise tolerance and performance up to 30 days after surgery 4. Determine the safety profile of intravenous iron isomaltoside and its effect on preoperative and postoperative haemoglobin and ferritin concentrations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

The inclusion criteria will be adults scheduled for elective cardiac surgery within 3-10 weeks with written informed consent, irrespective of their haemoglobin and iron status. We will recruit 460 consecutive patients undergoing major elective coronary artery bypass graft and/or valve surgery of anticipated duration of more than three hours.

Inclusion criteria

The inclusion criteria will be adults scheduled for elective cardiac surgery within 3-10 weeks with written informed consent, irrespective of their haemoglobin and iron status. We will recruit 460 consecutive patients undergoing major elective coronary artery bypass graft and/or valve surgery of anticipated duration of more than three hours.

排除标准：

We will exclude patients undergoing aortic dissection repair due to the intrinsic high risk of bleeding with this type of operation; emergency cardiac surgery; family or personal history of haemochromatosis; known reasons for anaemia, such as vitamin B12 or folate deficiency, haemoglobinopathy, thalassemia, chronic renal failure; previous intravenous iron therapy or blood transfusion in last 12 weeks; known hypersensitivity to intravenous iron therapy; body temperature more than 37.5°C or receiving non-prophylactic antibiotics; chronic liver disease and/or alanine aminotransferase or aspartate aminotransferase concentration above three times the upper limit of normal; history of asthma, allergic eczema or other atopic allergy; and rheumatoid arthritis with symptoms or signs of active inflammation.

Exclusion criteria：

We will exclude patients undergoing aortic dissection repair due to the intrinsic high risk of bleeding with this type of operation; emergency cardiac surgery; family or personal history of haemochromatosis; known reasons for anaemia, such as vitamin B12 or folate deficiency, haemoglobinopathy, thalassemia, chronic renal failure; previous intravenous iron therapy or blood transfusion in last 12 weeks; known hypersensitivity to intravenous iron therapy; body temperature more than 37.5°C or receiving non-prophylactic antibiotics; chronic liver disease and/or alanine aminotransferase or aspartate aminotransferase concentration above three times the upper limit of normal; history of asthma, allergic eczema or other atopic allergy; and rheumatoid arthritis with symptoms or signs of active inflammation.

研究实施时间：

Study execute time：

从 From 2018-07-02 00:00:00至 To 2024-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-07-02 00:00:00 至 To 2024-05-31 00:00:00

干预措施：

Interventions：

组别：

Single dose intravenous iron isomaltoside group

样本量：

 230

Group：

Single dose intravenous iron isomaltoside group

Sample size：

干预措施：

N/A

干预措施代码：

Intervention：

N/A

Intervention code：

组别：

No intravenous iron therapy group

样本量：

 230

Group：

No intravenous iron therapy group

Sample size：

干预措施：

N/A

干预措施代码：

Intervention：

N/A

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

 Hong Kong SAR 

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong SAR

单位(医院)：

 Prince of Wales Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Prevalence of anaemia and iron deficiency

指标类型：

主要指标

Outcome：

Prevalence of anaemia and iron deficiency

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Exercise performance

指标类型：

主要指标

Outcome：

Exercise performance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Days (alive and) at home within 30 days of surgery

指标类型：

主要指标

Outcome：

Days (alive and) at home within 30 days of surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Units of perioperative allogenic blood transfused

指标类型：

次要指标

Outcome：

Units of perioperative allogenic blood transfused

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Chinese Veterans Specific Activity Questionnaire

指标类型：

次要指标

Outcome：

Chinese Veterans Specific Activity Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cardiac Postoperative Morbidity Survey

指标类型：

次要指标

Outcome：

Cardiac Postoperative Morbidity Survey

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of Recovery-15 item

指标类型：

次要指标

Outcome：

Quality of Recovery-15 item

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

World Health Organization Disability Assessment Schedule 2.0

指标类型：

次要指标

Outcome：

World Health Organization Disability Assessment Schedule 2.0

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：

N/A

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age N/A 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)：

N/A

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：

Blinding：

是否共享原始数据：

IPD sharing

是Yes

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）：

Only group data will be published.

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

Only group data will be published.

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：

Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care. Hardcopy data will be destroyed 5 years after last publication of results. Electronic data password protected will be kept in project coordinator, research nurse and PI's office computers that are also password protected.

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

Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care. Hardcopy data will be destroyed 5 years after last publication of results. Electronic data password protected will be kept in project coordinator, research nurse and PI's office computers that are also password protected.

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：

  2023-05-30 11:28:51