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Clinical evaluation and mechanism of action of traditional Chinese medicine intervention in hemorrhagic transformation after intravenous thrombolytic therapy

注册号：

Registration number：

ITMCTR2024000613

最近更新日期：

Date of Last Refreshed on：

2024-10-27

注册时间：

Date of Registration：

2024-10-27

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中医药干预静脉溶栓治疗后出血转化的临床评价与作用机制研究

Public title：

Clinical evaluation and mechanism of action of traditional Chinese medicine intervention in hemorrhagic transformation after intravenous thrombolytic therapy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中医药干预静脉溶栓治疗后出血转化的临床评价与作用机制研究

Scientific title：

Clinical evaluation and mechanism of action of traditional Chinese medicine intervention in hemorrhagic transformation after intravenous thrombolytic therapy

研究课题的正式科学名称简写：

Scientific title acronym：

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：

齐大河

研究负责人：

孔令博

Applicant：

Qi dahe

Study leader：

Kong lingbo

申请注册联系人电话：

Applicant telephone：

+86 188 3892 3005

研究负责人电话：

Study leader's telephone：

+86 131 6732 3987

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：

qidahe123456@163.com

研究负责人电子邮件：

Study leader's E-mail：

klb1984@163.com

申请单位网址(自愿提供)：

Study leader's 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：

北京市朝阳区北三环东路11号北京中医药大学西校区

研究负责人通讯地址：

北京市东城区海运仓5号

Applicant address：

11Road Chaoyang District Beijing China

Study leader's address：

No.5 Haiyuncang Dongcheng District Beijing

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：

北京中医药大学

Applicant's institution：

Beijing University of Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2024DZMEC-324-02

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

北京中医药大学东直门医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee Dongzhimen Hospital Beijing University of Chinese Medicine China

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/26 0:00:00

伦理委员会联系人：

韩雪婷

Contact Name of the ethic committee：

Han xueting

伦理委员会联系地址：

北京市东城区海运仓5号

Contact Address of the ethic committee：

No.5 Haiyuncang Dongcheng District Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8401 2709

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hanxueting@163.com

研究实施负责（组长）单位：

北京中医药大学东直门医院

Primary sponsor：

Dongzhimen Hospital of Beijing University of Chinese Medicine

研究实施负责（组长）单位地址：

北京市东城区海运仓5号

Primary sponsor's address：

No.5 Haiyuncang Dongcheng District Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学东直门医院

具体地址：

北京市东城区海运仓5号

Institution
hospital：

Dongzhimen Hospital of Beijing University of Chinese Medicine

Address：

No.5 Haiyuncang Dongcheng District Beijing

经费或物资来源：

北京市通州区财政科技经费

Source(s) of funding：

Beijing Tongzhou District Financial Fund for Science and Technology

研究疾病：

急性缺血性卒中

研究疾病代码：

Target disease：

Acute ischemic stroke

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

（1）基于中医原创思维，从中医对急性缺血性卒中静脉溶栓治疗手段及其治疗后病理变化的认 识出发，精准定位中医药干预时机，开展针对性中药制剂的循证评价，为降低静脉溶栓治疗后出血 转化提供有效的治疗药物，为填补指南中的空白提供依据。 （2）以通州地区为示范，将证候评价与疾病评价、阶段性评价与结局性评价相结合，对益气摄 血法干预急性缺血性卒中静脉溶栓治疗出血转化的中药制剂进行临床有效性、安全性评价，提高循 证医学证据和认可度。 （3）利用临床样本，从炎性因子、凝血功能、氧化应激、蛋白受体等多层次、多角度探讨益气 摄血法防治静脉溶栓出血转化的作用机制。

Objectives of Study：

(1) Based on the original thinking of traditional Chinese medicine (TCM) from the recognition of TCM on the means of intravenous thrombolytic therapy for acute ischemic stroke and its post-treatment pathological change knowledge pinpointing the timing of TCM intervention carrying out evidence-based evaluation of targeted TCM preparations and providing effective therapeutic drugs to reduce bleeding after intravenous thrombolytic therapy We will conduct evidence-based evaluation of targeted Chinese medicinal preparations to provide effective therapeutic drugs to reduce bleeding after intravenous thrombolytic therapy and provide a basis for filling the gaps in the guidelines. (2) Taking Tongzhou as a model combining evidence evaluation with disease evaluation stage evaluation with outcome evaluation and evaluating the benefits of qi and blood intake methods for acute ischemic stroke. (2) Using the Tongzhou area as a model combining evidence evaluation with disease evaluation stage evaluation with outcome evaluation and evaluating the clinical validity and safety of the Chinese medicinal preparation for intravenous thrombolysis for hemorrhagic transformation in acute ischemic stroke with the intervention of the blood method so as to improve evidence-based medical evidence and recognition. evidence and recognition of evidence-based medicine. (3) Using clinical samples we will explore the mechanism of the blood regimen of Yiqi in preventing hemorrhagic transformation of venous thrombolysis from multiple levels and perspectives such as inflammatory factors coagulation function oxidative stress and protein receptor.

药物成份或治疗方案详述：

本研究采用的生脉注射液为江苏苏中药业集团生物制药有限公司生产，规格为20ml×3支/盒，药物成分主要为红参、麦冬、五味子。本研究预计纳入160例急性缺血性脑卒中患者，采用中心随机方式，每位受试者随机分到两组的概率均为50％，对照组予基于指南的规范化治疗（包括溶栓后的抗板、降压、降脂、降糖、改善循环等治疗）加以0.9%氯化钠注射液100ml，泵速20ml/h，1次/日，连续3天。试验组在基于指南的规范化治疗的基础上加以生脉注射液治疗。静脉溶栓后立即予生脉注射液100ml静脉泵入，泵速20ml/h，1次/日，连续3天，分别在溶栓后36h、7d、10d或出院时、发病90d进行相关信息的收集。

Description for medicine or protocol of treatment in detail：

The Shengwei injection used in this study was produced by Jiangsu Suzhong Pharmaceutical Group Biopharmaceutical Co. Ltd with the specification of 20 ml×3 sticks/box and the drug components were mainly red ginseng maitake and schizandra. This study is expected to include 160 cases of acute ischemic stroke patients using a central randomization method each subject was randomly assigned to two groups with a probability of 50%. The control group was given guideline-based standardized treatment (including anti-platelet antihypertensive lipid-lowering hypoglycemic and circulatory improvement treatments after thrombolytic therapy) plus 100ml of 0.9% sodium chloride injection with a pump rate of 20ml/h 1 time/day for 3 consecutive days. The experimental group was treated with Sheng Vein Injection on the basis of standardized treatment based on the guidelines. Immediately after intravenous thrombolysis 100 ml of Shengqin injection was intravenously pumped in with a pumping rate of 20 ml/h once/day for 3 consecutive days and the relevant information was collected at 36h 7d 10d after thrombolysis or at the time of discharge from the hospital or at 90d of the onset of the disease respectively.

纳入标准：

①符合急性缺血性卒中诊断标准；②接受静脉溶栓或介入取栓治疗；③NIHSS 分值≥3 分；④18岁≤年龄≤85岁；⑤受试者知情同意，并签署知情同意书。

Inclusion criteria

(i) met the diagnostic criteria for acute ischemic stroke; (ii) received intravenous thrombolysis or interventional thrombolysis; (iii) NIHSS score ≥ 3; (iv) 18 ≤ age ≤ 85; (v) subjects gave informed consent and signed an informed consent form.

排除标准：

①已知对生脉注射液或相关药物成份过敏者；②既往有卒中病史且遗留后遗症严重影响结局测评者，即本次卒中发病前改良Rankin量表得分≥2分；③合并有其他影响肢体活动功能的疾病，治疗前合并有跛行、骨关节炎、类风湿性关节炎、痛风性关节炎等引起的肢体活动功能障碍影响神经功能检查者；④合并严重肝、肾功能不全者（备注：肝功能不全是指ALT或AST值大于2倍正常上限，肾功能不全是指血肌酐值大于2倍正常上限）；⑤患有其他威胁生命的严重疾病，预期生存时间小于3个月者；⑥研究者认为可能限制神经功能评价或影响病人随访的其他疾病或精神病；⑦妊娠或哺乳期妇女；⑧正在参加其他药物临床试验者。

Exclusion criteria：

① Known allergy to Sheng pulse injection or related drug ingredients; ② previous history of stroke and sequelae seriously affect the outcome assessment that is before the onset of the current stroke modified Rankin Scale score ≥ 2; ③ combined with other diseases affecting the function of limb movement combined with claudication osteoarthritis rheumatoid arthritis gouty arthritis etc. caused by limb dysfunction affecting the neural function test; ④ combined with severe hepatic and renal insufficiency (Note: Liver dysfunction refers to ALT or AST value is greater than the upper limit of normal blood creatinine value is greater than the upper limit). Neurological function examination; ④ Combined severe hepatic and renal insufficiency (Note: hepatic insufficiency is defined as ALT or AST value greater than two times the upper limit of normal and renal insufficiency is defined as blood creatinine value greater than two times the upper limit of normal); ⑤ Suffering from other serious life-threatening diseases with an expected survival time of less than 3 months; ⑥ Other illnesses or psychiatric diseases that in the opinion of the investigator may limit the evaluation of neurological function or affect the patient's follow-up; ⑦ Pregnancy or lactation. ; ⑦ Pregnant or lactating women; ⑧ Those who are participating in clinical trials of other drugs.

研究实施时间：

Study execute time：

从From 2024-09-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2024-10-30

至To      2025-09-30

干预措施：

Interventions：

组别：

对照组

样本量：

80

Group：

control subjects

Sample size：

干预措施：

基于指南的规范化治疗（包括溶栓后的抗板、降压、降脂、降糖、改善循环等治疗）加以0.9%氯化钠注射液100ml，泵速20ml/h，1次/日，连续3天

干预措施代码：

Intervention：

Guideline-based standardized treatment (including antiplate antihypertensive hypolipidemic hypoglycemic and circulatory improvement therapy after thrombolysis) plus 100 ml of 0.9% sodium chloride injection at a pump rate of 20 ml/h once/day for 3 days

Intervention code：

组别：

试验组

样本量：

80

Group：

test group

Sample size：

干预措施：

基于指南的规范化治疗的基础上加以生脉注射液治疗。静脉溶栓后立即予生脉注射液100ml静脉泵入，泵速20ml/h，1次/日，连续3天。

干预措施代码：

Intervention：

Based on the standardized treatment based on the guideline the treatment was supplemented with Shengqi injection. Immediately after intravenous thrombolysis 100 ml of Shengqin injection was pumped intravenously at a rate of 20 ml/h once/day for 3 consecutive days.

Intervention code：

样本总量 Total sample size ： 160

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学东直门医院

单位级别：

三甲

Institution/hospital：

Dongzhimen Hospital of Beijing University of Chinese Medicine

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

beijing

City：

单位(医院)：

首都医科大学附属潞河医院

单位级别：

三甲

Institution/hospital：

Luhe Hospital, Capital Medical University

Level of the institution：

Tertiary A

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京朝阳中西医结合急诊抢救医院

单位级别：

三级

Institution/hospital：

Beijing Chaoyang Hospital of Integrative Medicine for Emergency and Rescue

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

凝血功能四项

指标类型：

副作用指标

Outcome：

Coagulation IV

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

缺血性中风证候要素诊断量表

指标类型：

次要指标

Outcome：

Diagnostic Scale for Ischemic Stroke Symptom Elements

Type：

Secondary indicator

测量时间点：

基线、溶栓后36h，7d，10d或出院时

测量方法：

Measure time point of outcome：

base line36h, 7d, 10d after thrombolysis or at hospital discharge

Measure method：

指标中文名：

血常规

指标类型：

副作用指标

Outcome：

routine blood test

Type：

Adverse events

测量时间点：

基线、溶栓后10d或出院时

测量方法：

Measure time point of outcome：

Baseline, 10 d after thrombolysis, or at hospital discharge

Measure method：

指标中文名：

核因子κB

指标类型：

次要指标

Outcome：

NF-κB

Type：

Secondary indicator

测量时间点：

溶栓后10d或出院时

测量方法：

Measure time point of outcome：

10d after thrombolysis

Measure method：

指标中文名：

溶栓后36h出血转化发生率

指标类型：

主要指标

Outcome：

Incidence of hemorrhagic conversion 36h after thrombolysis

Type：

Primary indicator

测量时间点：

静脉溶栓后36h

测量方法：

Measure time point of outcome：

36h after intravenous thrombolysis

Measure method：

指标中文名：

心电图

指标类型：

副作用指标

Outcome：

electrocardiography

Type：

Adverse events

测量时间点：

基线、溶栓后10d或出院时

测量方法：

Measure time point of outcome：

Baseline, 10 d after thrombolysis, or at hospital discharge

Measure method：

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

adverse event

Type：

Adverse events

测量时间点：

基线、溶栓后36h，7d，10d或出院时、发病 90±3d

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良Rankin量表

指标类型：

次要指标

Outcome：

Modification of the Rankin Scale

Type：

Secondary indicator

测量时间点：

基线、发病90±3d

测量方法：

Measure time point of outcome：

base line Onset 90±3d

Measure method：

指标中文名：

脑出血转化评分量表（ECASS2）

指标类型：

次要指标

Outcome：

European Cooperative Acute Stroke Study-Ⅱ

Type：

Secondary indicator

测量时间点：

溶栓后36h，7d，10d或出院时

测量方法：

Measure time point of outcome：

36h, 7d, 10d after thrombolysis or at hospital discharge

Measure method：

指标中文名：

巴氏指数量表

指标类型：

次要指标

Outcome：

Barthel Scale

Type：

Secondary indicator

测量时间点：

基线、发病90±3d

测量方法：

Measure time point of outcome：

base line Onset 90±3d

Measure method：

指标中文名：

肝功能、肾功能

指标类型：

副作用指标

Outcome：

Liver function, kidney function

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

缺血性中风证候要素评价量表

指标类型：

次要指标

Outcome：

Evaluation Scale for Ischemic Stroke Symptom Elements

Type：

Secondary indicator

测量时间点：

基线、溶栓后36h，7d，10d或出院时

测量方法：

Measure time point of outcome：

base line36h, 7d, 10d after thrombolysis or at hospital discharge

Measure method：

指标中文名：

美国国立卫生研究院卒中量表

指标类型：

次要指标

Outcome：

National Institutes of Health Stroke Scale

Type：

Secondary indicator

测量时间点：

基线、溶栓后36h，7d，10d或出院时

测量方法：

Measure time point of outcome：

base line36h, 7d, 10d after thrombolysis or at hospital discharge

Measure method：

指标中文名：

基质金属蛋白酶-9

指标类型：

次要指标

Outcome：

Matrix Metalloproteinase 9

Type：

Secondary indicator

测量时间点：

溶栓后10d或出院时

测量方法：

Measure time point of outcome：

10d after thrombolysis

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

血液

组织：

Sample Name：

hematology

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：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 85 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机对照，采用SAS生成随机号

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

Randomized control using SAS to generate random numbers

盲法：

双盲

Blinding：

double-blind (scientific experiment)

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）：

否

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

NO

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：

研究者根据原始观察记录，将数据及时、正确、完整、清晰地记录在病例报告表。每个入选病例必须完成病例报告表。由临床监查员审查后，移交数据管理员，进行数据录入与管理工作。数据的录入与修改：数据录入与管理由数据管理员负责。通过移动终端登录信息化平台进行数据录入。对病例报告表中存在的疑问，数据录入员将产生《数据录入疑问解答表》，并通过临床监查员向研究者发出询问，研究者应尽快解答并返回，数据录入员根据研究者的回答进行数据修改、确认与录入，必要时可以再次发出疑问解答表。 数据核查与校验：监查员对数据进行 100%核查，并在核查的过程中发出数据疑问，协调研究者解决。在研究现场电子和病案信息系统可以支持的情况下，监查员对全部纳入受试者的真实性和连续纳入的依从性进行核查。本研究的数据录入采用在线电子数据录入系统，由研究者完成数据录入。电子数据录入系统设置必要的数据合法值和逻辑校验规则，以提醒研究者可能的异常值或数据逻辑错误。 数据传输：研究采用基于网络的电子数据管理系统，由研究者完成数据录入后上传至数据中心。研究数据从数据中心下载后移交给研究组长单位、申办方和统计分析人员。所有的数据交接过程应保留书面的记录。 数据锁定：完成数据录入后，由课题负责单位人员、统计分析人员对数据进行锁定。锁定后的数据文件不再做改动。数据锁定之后发观的问题，经确认后在统计分析程序中进行修正。 数据处理：在研究数据全部录入并锁定后，将数据库交统计分析人员按统计计划书要求进行统计分析。由统计分析人员写出统计分析报告，交课题负责单位。

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

The investigator recorded the data in a timely correct complete and legible manner on the case report form based on the original observation records. The case report form must be completed for each enrolled case. After being reviewed by the clinical supervisor it will be transferred to the data manager for data entry and management. Data entry and modification: Data entry and management is the responsibility of the data administrator. Data entry is performed by logging into the information technology platform through the mobile terminal. For the questions existing in the case report form the data entry operator will generate the Data Entry Question and Answer Form and send the inquiry to the investigator through the clinical supervisor who should answer and return as soon as possible and the data entry operator will carry out the data modification confirmation and entry according to the investigator's answer and can send out the question and answer form again if necessary. Data verification and validation: The Supervisor verifies 100% of the data and during the verification process issues data queries and coordinates with the investigator to resolve them. Verification of authenticity and adherence to continuous enrollment of all included subjects was performed by the supervisors when supported by the study site's electronic and case information system. Data entry for this study was accomplished by the investigator using an online electronic data entry system. The electronic data entry system was set up with the necessary data legitimacy values and logical checking rules to alert the researcher to possible outliers or logical errors in the data. Data transfer: The study uses a web-based electronic data management system where data entry is completed by the researcher and uploaded to the data center. The study data are downloaded from the data center and transferred to the study team leader unit the sponsor and the statistical analyst. Written records should be kept of all data handovers. Data locking: After completing the data entry the data will be locked by the personnel of the responsible unit and the statistical analyst. No further changes will be made to the data file after locking. Problems observed after data locking will be corrected in the statistical analysis program after confirmation. Data processing: After all the research data are entered and locked the database will be handed over to the statistical analyst for statistical analysis according to the requirements of the statistical program. The statistical analyst will write a statistical analysis report and submit it to the unit in charge of the project.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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