ChiCTR2100048420 版本V1.4 版本创建时间2022/03/14 12:15:26 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:

ChiCTR2100048420 

最近更新日期:

Date of Last Refreshed on:

2022-03-14 12:14:04 

注册时间:

Date of Registration:

2021-07-06 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

严重创伤患者伤后免疫功能紊乱的临床及试验研究

Public title:

Clinical and experimental study on post-traumatic immune dysfunction in patients with severe trauma

注册题目简写:

English Acronym:

研究课题的正式科学名称:

严重创伤患者伤后免疫功能紊乱的临床及试验研究

Scientific title:

Clinical and experimental study on post-traumatic immune dysfunction in patients with severe trauma

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:

唐朝晖 

研究负责人:

唐朝晖 

Applicant:

Tang Zhaohui 

Study leader:

Tang Zhaohui 

申请注册联系人电话:

Applicant telephone:

+86 13971125289

研究负责人电话:

Study leader's
telephone:

+86 13971125289

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:

tangzh@tjh.tjmu.cn

研究负责人电子邮件:

Study leader's E-mail:

tangzh@tjh.tjmu.cn

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:

湖北省武汉市硚口区解放大道1095号

研究负责人通讯地址:

湖北省武汉市硚口区解放大道1095号

Applicant address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei

Study leader's address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei

申请注册联系人邮政编码:

Applicant postcode:

430030

研究负责人邮政编码:

Study leader's postcode:

430030

申请人所在单位:

华中科技大学,同济医学院附属同济医院

Applicant's institution:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究负责人所在单位:

华中科技大学,同济医学院附属同济医院

Affiliation of the Leader:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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:

TJ-IRB20200720

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:

华中科技大学同济医学院附属同济医院医学伦理委员会

Name of the ethic committee:

Medical ethics committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-22 00:00:00

伦理委员会联系人:

杜艾桦

Contact Name of the ethic committee:

Du Aihua

伦理委员会联系地址:

湖北省武汉市硚口区解放大道1095号

Contact Address of the ethic committee:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei

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:

华中科技大学,同济医学院附属同济医院

Primary sponsor:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责(组长)单位地址:

湖北省武汉市硚口区解放大道1095号

Primary sponsor's address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

同济医院

具体地址:

硚口区解放大道1095号

Institution
hospital:

Tongji Hospital

Address:

1095 Jiefang Avenue, Qiaokou District

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation of China

研究疾病:

N/A  

Target disease:

N/A

研究疾病代码:

T01.901

Target disease code:

T01.901

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:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

研究目的:

拟观察严重创伤患者伤后免疫功能紊乱的调节。  

Objectives of Study:

To observe the regulation of post-traumatic immune dysfunction in patients with severe trauma.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1.创伤组:
(1)性别:男性;
(2)年龄:18-50岁;
(3)伴下肢闭合性骨折严重患者;
(4)ISS≥16分。
2.对照组(健康自愿者):
(1)性别:男性;
(2)年龄:18-50岁;
(3)健康情况良好,无心、肝、肾、消化道、神经系统以及精神异常及代谢异常等病史;
(4)无免疫类相关疾病,既往未使用免疫增强剂或免疫抑制类药物;
(5)签署知情同意书。

Inclusion criteria

1. Trauma group:
(1) Gender: male;
(2) Aged 18-50 years old;
(3) Patients with severe closed fracture of lower extremity;
(4) ISS>=16 points.
2. Control group (healthy volunteers):
(1) Gender: male;
(2) Aged 18-50 years old;
(3) Good health, no history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic disorders;
(4) No immune-related diseases, and no immune-enhancing or immunosuppressive drugs have been used before;
(5) Sign the informed consent.

排除标准:

1.创伤组(有以下一种及以上情况的):
(1)开放性损伤患者;
(2)长期激素或免疫抑制治疗患者;
(3)有免疫缺陷病史,包括HIV阳性或类风湿性关节炎、红斑狼疮、重症肌无力、慢性肾小球肾炎等基础免疫系统慢性疾,或有器官移植史者;
(4)入院时有发热(体温>38.5℃),并伴有血白细胞计数升高和血沉增快;
(5)患者存活时间<7天。
2.对照组(有以下一种及以上情况的):
(1)经体格检查血压、心电图、呼吸状况或肝肾功能、血尿常规异常(经临床医师判断有临床意义);
(2)在过去的一年中,有酗酒史、嗜烟史、药物滥用史或吸毒史;
(3)入选前三个月内,参加过药物试验或使用过相关免疫制剂;
(4)试验开始前两周内使用过任何其他药物;
(5)不能耐受静脉穿刺采血;
(6) 正在参与其他临床实验者。

Exclusion criteria:

1. Trauma group (with one or more of the following conditions):
(1) Patients with open injury;
(2) Patients on long-term hormone or immunosuppressive therapy;
(3) Those with a history of immunodeficiency, including HIV positive or rheumatoid arthritis, lupus erythematosus, myasthenia gravis, chronic glomerulonephritis and other basic chronic diseases of the immune system, or a history of organ transplantation;
(4) Fever (body temperature >38.5℃) on admission, accompanied by increased white blood cell count and increased erythrocyte sedimentation rate;
(5) The patient's survival time is less than 7 days.
2. Control group (with one or more of the following conditions):
(1) Abnormal blood pressure, electrocardiogram, respiratory status or liver and kidney function, and routine blood and urine routine examinations (judged by clinicians to have clinical significance);
(2) History of alcoholism, smoking, drug abuse or drug use in the past year;
(3) Participated in drug trials or used related immune preparations within three months before enrollment;
(4) Have used any other drugs within two weeks before the start of the trial;
(5) Inability to tolerate venipuncture for blood collection;
(6) Those who are participating in other clinical experiments.

研究实施时间:

Study execute time:

From 2021-07-05 00:00:00 To 2021-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2021-07-05 00:00:00 To 2021-12-31 00:00:00

干预措施:

Interventions:

组别:

创伤组

样本量:

70

Group:

Trauma group

Sample size:

干预措施:

按照创伤指南治疗

干预措施代码:

Intervention:

Follow trauma guidelines

Intervention code:

组别:

对照组

样本量:

70

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

外周血Tim-3阳性NKT

指标类型:

主要指标

Outcome:

Tim-3 positive peripheral blood NKT cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

白介素12

指标类型:

主要指标

Outcome:

IL-12

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

凋亡NKT细胞

指标类型:

主要指标

Outcome:

Apoptosis NKT cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

干扰素-r

指标类型:

主要指标

Outcome:

Interferon-r

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白细胞介素-6

指标类型:

主要指标

Outcome:

IL-6

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白细胞介素-10

指标类型:

主要指标

Outcome:

IL-10

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

外周血Tim-3阳性NK细胞

指标类型:

主要指标

Outcome:

Tim-3 positive peripheral blood NK cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

凋亡NK细胞

指标类型:

主要指标

Outcome:

Apoptosis NK cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

外周血Tim-3阳性CD4+T细胞

指标类型:

主要指标

Outcome:

Tim-3 positive peripheral blood CD4+T cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

凋亡CD4+T细胞

指标类型:

主要指标

Outcome:

ApoptosisCD4+T cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

外周血Tim-3阳性CD8+T细胞

指标类型:

主要指标

Outcome:

Tim-3 positive peripheral blood CD8+T cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

凋亡CD8+T细胞

指标类型:

主要指标

Outcome:

ApoptosisCD8+T cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

超敏C反应蛋白

指标类型:

主要指标

Outcome:

High-sensitivity C-reactive protein

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

免疫增强比浊法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Enhanced turbidimetric inhibition immuno assay

指标中文名:

高敏肌钙蛋白-I

指标类型:

主要指标

Outcome:

High-sensitivity troponin-I

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

化学发光微粒子免疫检测技术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Chemiluminescent microparticle immunodetection technology

指标中文名:

胱抑素C

指标类型:

主要指标

Outcome:

Cystatin C

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

免疫比浊法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Immunoturbidimetry

指标中文名:

乳酸

指标类型:

主要指标

Outcome:

Lactic acid

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

比色法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Colorimetry

指标中文名:

谷丙转氨酶

指标类型:

主要指标

Outcome:

Alanine aminotransferase

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

IFCC法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

IFCC

指标中文名:

谷草转氨酶

指标类型:

主要指标

Outcome:

Aspartate aminotransferase

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

比色法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Colorimetry

指标中文名:

凝血酶原时间

指标类型:

主要指标

Outcome:

Prothrombin time

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

凝固法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Blood coagulometer

指标中文名:

活化部分凝血活酶时间

指标类型:

主要指标

Outcome:

Activated partial thromboplastin time

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

凝固法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Blood coagulometer

指标中文名:

D-D二聚体

指标类型:

主要指标

Outcome:

D-D dimer

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

免疫比浊法进行检测

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Immunoturbidimetry

指标中文名:

国际标准化比值

指标类型:

主要指标

Outcome:

International normalized ratio

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

脑型利钠肽前体

指标类型:

主要指标

Outcome:

NT-proBNP

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

降钙素原

指标类型:

主要指标

Outcome:

Procalcitonin

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白细胞计数

指标类型:

主要指标

Outcome:

White blood cell count

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

血小板计数

指标类型:

主要指标

Outcome:

Platelet count

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

前白蛋白

指标类型:

主要指标

Outcome:

Prealbumin

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白蛋白

指标类型:

主要指标

Outcome:

Albumin

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白细胞介素-8

指标类型:

主要指标

Outcome:

IL-8

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

肿瘤坏死因子-α

指标类型:

主要指标

Outcome:

TNF-alpha

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白介素-2受体

指标类型:

主要指标

Outcome:

IL-2r

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白介素1β

指标类型:

主要指标

Outcome:

IL-1 beta

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

创伤严重程度评分

指标类型:

主要指标

Outcome:

Injury severity score

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

急性生理与慢性健康评分-II

指标类型:

主要指标

Outcome:

Acute physiology and chronic health score-II

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

简明损伤定级标准

指标类型:

主要指标

Outcome:

Brief damage grading criteria

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

格拉斯哥昏迷评分

指标类型:

主要指标

Outcome:

Glasgow coma score

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

年龄

指标类型:

主要指标

Outcome:

Age

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别

指标类型:

主要指标

Outcome:

Sex

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

主要指标

Outcome:

Heart rate

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

血压

指标类型:

主要指标

Outcome:

Blood pressure

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

体温

指标类型:

主要指标

Outcome:

Body temperature

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

血气

指标类型:

主要指标

Outcome:

Arterial blood gas

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

指标中文名:

白介素-23

指标类型:

主要指标

Outcome:

IL-23

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白介素-27

指标类型:

主要指标

Outcome:

IL-27

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

白介素-18

指标类型:

主要指标

Outcome:

IL-18

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

酶联免疫吸附测定法

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

ELISA

指标中文名:

外周血Tim-3阴性NKT

指标类型:

主要指标

Outcome:

Tim-3 negative peripheral blood NKT cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞术

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

凋亡Tim-3阳性NKT细胞

指标类型:

主要指标

Outcome:

Apoptosis Tim-3 positive peripheral blood NKT cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

指标中文名:

凋亡Tim-3阴性NKT细胞

指标类型:

主要指标

Outcome:

Apoptosis Tim-3 negative peripheral blood NKT cells

Type:

Primary indicator

测量时间点:

伤后第1,3,7天

测量方法:

流式细胞

Measure time point of outcome:

1, 3, and 7 days after injury

Measure method:

Flow cytometry

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

外周血

Sample Name:

Blood

Tissue:

Peripheral blood

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 50 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):

非随机

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

non randomized control

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:

N/A

Blinding:

N/A

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

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):

www.medresman.org.cn

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

www.medresman.org.cn

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:

www.medresman.org.cn

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

www.medresman.org.cn

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-07-06 07:50:15