ChiCTR2600121962 版本V1.0 版本创建时间2026/04/07 17:02:03 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：

 ChiCTR2600121962 

最近更新日期：

Date of Last Refreshed on：

 2026-04-07 17:01:46 

注册时间：

Date of Registration：

 2026-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

西维来司他钠辅助治疗脑出血后卒中相关性肺炎的有效性及安全性：一项单中心、前瞻性、随机对照试验

Public title：

Efficacy and Safety of Sivelestat Sodium as an Adjunctive Therapy for Stroke-Associated Pneumonia after Intracerebral Hemorrhage: A Single-Center, Prospective, Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

西维来司他钠辅助治疗脑出血后卒中相关性肺炎的有效性及安全性：一项单中心、前瞻性、随机对照试验

Scientific title：

Efficacy and Safety of Sivelestat Sodium as an Adjunctive Therapy for Stroke-Associated Pneumonia after Intracerebral Hemorrhage: A Single-Center, Prospective, Randomized Controlled Trial

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：

张鸿立 

研究负责人：

杨光 

Applicant：

Zhang Hongli 

Study leader：

Yang Guang 

申请注册联系人电话：

Applicant telephone：

 +86 181 4569 7860

研究负责人电话：

Study leader's
telephone：

+86 187 4607 2927

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：

 yunduanyyds@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 yangguang@hrbmu.edu.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：

黑龙江省哈尔滨市南岗区邮政街23号

研究负责人通讯地址：

黑龙江省哈尔滨市南岗区邮政街23号

Applicant address：

No. 23, Postal Street, Nangang District, Harbin City, Heilongjiang Province

Study leader's address：

No. 23, Postal Street, Nangang District, Harbin City, Heilongjiang Province

申请注册联系人邮政编码：

Applicant postcode：

 150001

研究负责人邮政编码：

Study leader's postcode：

 150001

申请人所在单位：

哈尔滨医科大学附属第一医院

Applicant's institution：

First Affiliated Hospital of Harbin Medical University

研究负责人所在单位：

哈尔滨医科大学附属第一医院

Affiliation of the Leader：

First Affiliated Hospital of Harbin Medical University

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：

 哈医一 伦审2026XS20-02(研2025509)

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：

哈尔滨医科大学附属第一医院伦理委员会

Name of the ethic committee：

The Ethics Committee of First Affiliated Hospital of Harbin Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-30 00:00:00

伦理委员会联系人：

鲍美汐

Contact Name of the ethic committee：

Meixi Bao

伦理委员会联系地址：

黑龙江省哈尔滨市南岗区邮政街23号

Contact Address of the ethic committee：

No. 23, Postal Street, Nangang District, Harbin City, Heilongjiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 151 0462 4790

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：

哈尔滨医科大学附属第一医院

Primary sponsor：

First Affiliated Hospital of Harbin Medical University

研究实施负责（组长）单位地址：

黑龙江省哈尔滨市南岗区邮政街23号

Primary sponsor's address：

No. 23, Postal Street, Nangang District, Harbin City, Heilongjiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

黑龙江

市(区县)：

哈尔滨

Country：

China

Province：

Heilongjiang

City：

Harbin

单位(医院)：

哈尔滨医科大学附属第一医院

具体地址：

黑龙江省哈尔滨市南岗区邮政街23号

Institution
hospital：

First Affiliated Hospital of Harbin Medical University

Address：

No. 23, Postal Street, Nangang District, Harbin City, Heilongjiang Province

经费或物资来源：

国家自然科学基金——82572145

Source(s) of funding：

National Natural Science Foundation of China——82572145

研究疾病：

自发性脑出血  

Target disease：

Spontaneous Intracerebral Hemorrhage

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探究西维来司他钠的添加使用是否可以减少自发性脑出血患者卒中相关性肺炎的发生和减轻肺炎严重程度  

Objectives of Study：

To investigate whether the addition of Sivelestat Sodium can reduce the occurrence and alleviate the severity of stroke-associated pneumonia in patients with spontaneous intracerebral hemorrhage.

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.年龄大于等于 18 岁且小于等于80岁； 2.经计算机断层扫描确诊为急性脑出血； 3.脑出血发作后24 小时内入院； 4.入院时GCS评分＞5分或NIHSS评分＜21分。

Inclusion criteria

1. Age >= 18 years and <= 80 years; 2. Acute intracerebral hemorrhage confirmed by computed tomography (CT) scan 3. Hospital admission within 24 hours of the onset of the cerebral hemorrhage 4. A Glasgow Coma Scale (GCS) score of >5 or a National Institutes of Health Stroke Scale (NIHSS) score of <21 at the time of admission.

排除标准：

1.出血原因明确为外伤、动脉瘤或肿瘤卒中（非自发性脑出血）； 2.血肿破入脑室者； 3.计划进行手术清除血肿； 4.存在慢性呼吸衰竭病史； 5.有显著残疾史(改良Rankin量表评分为>3)； 6.严重肾病(即需要透析的肾功能障碍)或估计的肾小球滤过率<30ml/min/1.73m^2； 7.严重肝病，或丙氨酸转氨酶>3倍或胆红素>2倍正常上限； 8.妊娠或哺乳期妇女； 9.近3个月内有急性ST段抬高梗死、失代偿性心力衰竭、心脏骤停、急性冠脉综合征或已知急性冠脉综合征、急性心肌梗死、冠脉介入史者； 10.过去7天内曾使用西维来司他钠治疗急性肺损伤/COPD者； 11.对西维来司他钠过敏； 12.由于其他疾病而非当前脑内出血导致的预期寿命小于3个月； 13.正在参加其他研究并接受试验性药物治疗。

Exclusion criteria：

1. Hemorrhage with a clear cause such as trauma, aneurysm, or tumoral stroke (i.e., non-spontaneous intracerebral hemorrhage); 2. Presence of intraventricular extension of the hematoma; 3. Planned surgical evacuation of the hematoma; 4. History of chronic respiratory failure; 5. History of significant pre-existing disability (modified Rankin Scale score >3); 6. Severe renal disease (i.e., renal dysfunction requiring dialysis) or an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2; 7. Severe liver disease, or alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN), or bilirubin >2 times ULN; 8. Pregnancy or lactation; 9. Acute ST-elevation myocardial infarction, decompensated heart failure, cardiac arrest, acute coronary syndrome, known acute coronary syndrome, acute myocardial infarction, or history of coronary intervention within the past 3 months; 10. Treatment with Sivelestat Sodium for acute lung injury/COPD within the past 7 days; 11. Known allergy to Sivelestat Sodium; 12. A life expectancy of less than 3 months due to conditions other than the current intracerebral hemorrhage; 13. Concurrent participation in another clinical trial involving investigational drug therapy.

研究实施时间：

Study execute time：

从 From 2026-04-15 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-15 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 240

Group：

Intervention Group

Sample size：

干预措施：

西维来司他钠静脉输注

干预措施代码：

Intervention：

Intravenous infusion of Sivelestat Sodium

Intervention code：

组别：

对照组

样本量：

 240

Group：

Control Group

Sample size：

干预措施：

安慰剂静脉输注

干预措施代码：

Intervention：

Intravenous administration of placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江 

市(区县)：

 哈尔滨 

Country：

China

Province：

Heilongjiang

City：

Harbin

单位(医院)：

 哈尔滨医科大学附属第一医院 

单位级别：

 三甲 

Institution
hospital：

First Affiliated Hospital of Harbin Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

自发性脑出血患者卒中相关性肺炎的发生率

指标类型：

主要指标

Outcome：

Incidence of stroke-related pneumonia in patients with spontaneous intracerebral hemorrhage

Type：

Primary indicator

测量时间点：

入院后7天内

测量方法：

临床监测：每日巡查，记录新出现的发热、咳嗽、咳痰、呼吸困难等呼吸道症状。 影像学确诊：对疑似病例立即进行肺部CT检查，由不知分组的专家确认是否存在新发肺部浸润影。 实验室支持：检测C反应蛋白、降钙素原等炎症标志物水平作为辅助证据。

Measure time point of outcome：

Within 7 days after admission

Measure method：

Clinical monitoring: Daily rounds to record new respiratory symptoms such as fever, cough, sputum production, and dyspnea. Imaging confirmation: Immediate chest CT scan for suspected cases, confirmed by blinded experts for the presence of new pulmonary infiltrates. Laboratory support: Detection of inflammatory markers such as C-reactive protein and procalcitonin levels as supportive evidence.

指标中文名：

卒中相关性肺炎的严重程度（基于CURB-65评分和PSI评分）

指标类型：

次要指标

Outcome：

Severity of stroke-associated pneumonia in patients with spontaneous intracerebral hemorrhage (Based on CURB-65 score, PSI score).

Type：

Secondary indicator

测量时间点：

入院后7天内

测量方法：

确诊卒中相关性肺炎后，使用CURB-65 评分量表和PSI评分量表进行评分

Measure time point of outcome：

Within 7 days after admission

Measure method：

After confirming stroke-associated pneumonia, the CURB-65 scoring scale and PSI scoring scale are used for scoring

指标中文名：

呼吸功能指标：确诊后第1天、第3天的氧合指数。

指标类型：

次要指标

Outcome：

Respiratory function indicators: Oxygenation index on day 1 and day 3 after diagnosis.

Type：

Secondary indicator

测量时间点：

患者发生卒中相关性肺炎后当天和第三天

测量方法：

动脉血氧分压与吸入氧浓度的比值

Measure time point of outcome：

On the day and the third day after the patient developed stroke-associated pneumonia

Measure method：

Ratio of arterial partial pressure of oxygen to inspired oxygen concentration

指标中文名：

血常规指标：确诊后第1天、第3天的白细胞计数

指标类型：

次要指标

Outcome：

Complete blood count indicators: White blood cell count on day 1 and day 3 after diagnosis.

Type：

Secondary indicator

测量时间点：

卒中相关性肺炎发生后当天和第三天

测量方法：

血常规检查

Measure time point of outcome：

Day 1 and day 3 after stroke-related pneumonia

Measure method：

complete blood count (CBC)

指标中文名：

炎症指标：确诊后第1天、第3天的C反应蛋白与降钙素原水平。

指标类型：

次要指标

Outcome：

Inflammatory markers: C-reactive protein and procalcitonin levels on day 1 and day 3 after diagnosis.

Type：

Secondary indicator

测量时间点：

患者发生卒中相关性肺炎后第一天和第三天

测量方法：

血炎症标志物检查

Measure time point of outcome：

On the day and the third day after the patient developed stroke-associated pneumonia

Measure method：

Blood inflammation marker test

指标中文名：

患者ICU住院时间

指标类型：

次要指标

Outcome：

Length of ICU stay

Type：

Secondary indicator

测量时间点：

患者出院时

测量方法：

患者出院时记录患者于ICU内的住院时间

Measure time point of outcome：

When patients are discharged

Measure method：

Record the patient's length of stay in the ICU when they are discharged

指标中文名：

患者住院期间不良反应（肝功能异常、呼吸困难、白细胞减少、血小板减少、深静脉血栓等）发生率

指标类型：

次要指标

Outcome：

Incidence of adverse reactions during hospitalization (including abnormal liver function, dyspnea, leukopenia, thrombocytopenia, deep vein thrombosis, etc.)

Type：

Secondary indicator

测量时间点：

整个住院期间

测量方法：

肝功能异常、白细胞减少、血小板减少由临床化验得到。呼吸困难由护理人员记录，深静脉血栓由下肢彩超确诊

Measure time point of outcome：

Throughout the hospitalization period

Measure method：

Abnormal liver function, leukopenia, and thrombocytopenia were obtained through clinical laboratory tests. Dyspnea was recorded by nursing staff, and deep vein thrombosis was confirmed by lower extremity color Doppler ultrasound

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

由独立统计学家使用计算机生成区组随机化序列（Block Randomization），区组长度设置为4或6或8（根据预计总样本量调整），确保组间人数均衡。随机化按1:1比例分配至：干预组（西维来司他钠+标准疗法）；对照组（安慰剂+标准疗法）

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

Randomization was performed by an independent statistician using computer-generated block randomization, with block sizes set at 4, 6, or 8 (adjusted according to the estimated total sample size) to ensure balanced group sizes. Participants were allocated in a 1:1 ratio to: the intervention group (Sivelestat Sodium + standard therapy) and the control group (placebo + standard therapy).

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：

双盲（对受试者和研究者均设盲）

Blinding：

Double blind (blinded to both subjects and researchers)

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）：

为促进科学研究的透明性与协作性，在本研究主要结果论文发表后，我们将根据合理的请求，在保护参与者隐私和符合伦理规范的前提下，与学术界同仁共享本研究的部分数据。 1. 共享数据范围 共享的数据集为去标识化后的个体参与者数据，即移除所有可直接或间接识别参与者身份的信息（如姓名、身份证号、精确入院日期等）。具体包括： 基线数据（如人口统计学信息、既往病史、入院时临床评分等）。 主要疗效终点数据（如90天改良Rankin量表评分）。 次要疗效终点数据（如系列影像学测量的血肿体积、水肿参数等）。 安全性数据（如不良事件记录、实验室检查异常值等）。 2. 数据获取条件与流程 数据共享需遵循以下条件，并通过规范的申请流程： 资格：数据请求方必须来自合法的学术研究机构或医疗卫生组织。 目的：数据申请必须用于独立的科学验证或经同行评审批准的Meta分析等学术目的，商业用途不予批准。 流程： 提案提交：有意获取数据的研究者需向本研究主要研究者（PI）提交一份简短的研究方案（1-2页），明确阐述其研究问题、分析计划及伦理考量。 审批：提案将由本研究主要研究者（PI）及指导委员会共同审阅。审批标准包括科学价值、方法严谨性以及是否符合本研究伦理许可的规定。 协议签署：提案获批后，数据请求方需签署一份数据使用协议，承诺仅将数据用于申请获批的目的，不试图识别参与者身份，不在协议范围外共享数据，并在项目完成后按规定销毁数据。 数据交付：数据将通过安全的加密文件传输方式提供。 3. 数据共享时间 自本研究主要结果论文在学术期刊上正式发表后6个月起，开始接受数据共享申请。共享期限至少为论文发表后的5年。 4. 其他相关资源的共享 除个体参与者数据外，以下资源也可根据合理请求提供： 研究方案：本研究已注册的试验方案（含统计分析计划）。 知情同意书：研究使用的知情同意书模板（不含参与者签名）。 统计分析代码：用于生成论文中主要结果的R或相关统计软件代码。 5. 联系人信息 有关数据共享的任何咨询与申请，请通过电子邮件联系本研究的主要研究者（PI）：yangguang@hrbmu.edu.cn 我们致力于推动科学进步，但出于对研究参与者隐私和权利的绝对保护，我们保留对任何数据请求的最终决定权。

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

Data Sharing StatementTo promote transparency and collaboration in scientific research, following the publication of the primary results of this study, de-identified data will be made available to academic researchers upon reasonable request, contingent upon the protection of participant privacy and adherence to ethical guidelines. 1. Types of Data Available for SharingThe shared dataset will consist of de-identified individual participant data, meaning all direct and indirect identifiers (e.g., name, ID number, exact admission dates) have been removed. Specifically, this includes:? Baseline Data: Demographic information, medical history, clinical scores at admission (e.g., NIHSS, GCS).? Primary Efficacy Endpoint Data: 90-day modified Rankin Scale (mRS) scores.? Secondary Efficacy Endpoint Data: Serially measured imaging parameters, such as hematoma volume and perihematomal edema (PHE) metrics.? Safety Data: Records of adverse events and laboratory abnormalities.2. Data Access Criteria and ProcedureData sharing is subject to the following conditions and must follow a formal application process:? Eligibility: Requestors must be affiliated with a legitimate academic research institution or healthcare organization.? Purpose: Data requests must be for independent scientific validation, peer-reviewed meta-analyses, or other bona fide academic purposes. Commercial use is expressly prohibited.? Procedure: 1. Proposal Submission: Interested researchers must submit a brief research proposal (1-2 pages) to the Principal Investigator (PI) of this study. The proposal should clearly outline the research question, analysis plan, and ethical considerations. 2. Approval Process: Submitted proposals will be reviewed by the study's PI and steering committee. Approval will be based on scientific merit, methodological rigor, and compliance with the ethical permissions of this study. 3. Data Use Agreement (DUA): Upon proposal approval, the requestor will be required to sign a legally binding DUA. This agreement will mandate that the data be used solely for the approved purpose, that no attempt will be made to re-identify participants, that the data will not be shared with third parties, and that the data will be securely destroyed upon project completion. 4. Data Transfer: Approved data will be provided via secure, encrypted file transfer methods.3. Timing of Data AvailabilityData sharing requests will be accepted starting 6 months after the publication of the primary research paper in a peer-reviewed journal. The data will remain available for sharing for a minimum of 5 years post-publication. 4. Availability of Additional Study ResourcesIn addition to individual participant data, the following resources may be available upon reasonable request:? Study Protocol: The registered trial protocol, including the statistical analysis plan (SAP).? Informed Consent Form (ICF): The template of the informed consent form used in the study (excluding participant signatures).? Analytic Code: Statistical analysis code (e.g., R, SAS) used to generate the primary results reported in the publication. 5. Contact InformationFor any inquiries or to submit a data access request, please contact the Principal Investigator (PI) via email:yangguang@hrbmu.edu.cn 6. Important NoteWhile we are committed to advancing scientific knowledge, the ultimate decision regarding any data request rests with the investigators, who are obligated to prioritize the absolute protection of participant privacy and rights.

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：

为确保研究数据的准确性、完整性和可靠性，本研究采用“以纸质病例记录表（CRF）为源数据，以基于ResMan平台构建的电子数据采集（EDC）系统为核心数据库”的混合管理模式，兼顾临床现场操作的便利性与现代化数据管理的严谨性。在该体系下，所有临床数据首先由研究人员准确、完整地记录于精心设计、高度结构化的纸质CRF上，任何修改均需划线更正并签名签注日期，以保证原始记录可追溯，且主要研究者（PI）对CRF数据的真实性与完整性负最终责任。随后，经培训的数据管理员将纸质CRF数据独立录入至ResMan临床研究管理平台，该系统作为中央数据库与质量控制中枢，可实现双人独立录入与差异比对，并通过预设逻辑核查规则在录入时实时检查数据，自动触发异常值、逻辑矛盾或缺失项的质询。此外，ResMan平台完整记录所有数据操作的电子审计轨迹，包括操作人、时间戳及修改原因，形成不可篡改的审计追踪，全面符合GCP对数据可靠性的要求，并支持从数据采集、质疑管理到数据锁库的全流程闭环管理。

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

To ensure the accuracy, completeness, and reliability of the study data, this study adopts a hybrid management model described as "using paper?based case report forms (CRFs) as the source data and the ResMan?platform?based electronic data capture (EDC) system as the core database," balancing the convenience of on?site clinical operations with the rigor of modern data management. Under this system, all clinical data are first accurately and completely recorded by research staff on carefully designed, highly structured paper CRFs; any corrections must be made by striking through the original entry, signing, and dating to ensure traceability of the source records, and the principal investigator (PI) bears ultimate responsibility for the authenticity and integrity of the CRF data. Subsequently, trained data managers independently enter the paper CRF data into the ResMan clinical research management platform. Serving as the central database and quality?control hub, the platform supports dual independent data entry with discrepancy comparison and performs real?time data checks during entry through preset logic validation rules, automatically triggering queries for outliers, logical inconsistencies, or missing items. Furthermore, the ResMan platform maintains a complete electronic audit trail of all data operations, including the operator, timestamp, and reason for changes, creating an indelible audit trail that fully complies with Good Clinical Practice (GCP) requirements for data reliability, and supports closed?loop management throughout the entire process from data collection and query management to database lock.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-04-07 17:01:46