ChiCTR2600124390 版本V1.0 版本创建时间2026/05/11 17:57:46 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:

ChiCTR2600124390 

最近更新日期:

Date of Last Refreshed on:

2026-05-11 17:57:29 

注册时间:

Date of Registration:

2026-05-11 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

评估短期糖皮质激素冲击对重症颅内静脉血栓患者临床结局的影响:一项整合动态蛋白组学分析的随机对照试验

Public title:

Evaluation of the impact of short-term glucocorticoid pulse therapy on clinical outcome the patients with severe cerebral venous thrombosis: A randomized controlled trial integrating dynamic proteomics analysis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

评估短期糖皮质激素冲击对重症颅内静脉血栓患者临床结局的影响:一项整合动态蛋白组学分析的随机对照试验

Scientific title:

Evaluation of the impact of short-term glucocorticoid pulse therapy on clinical outcome the patients with severe cerebral venous thrombosis: A randomized controlled trial integrating dynamic proteomics analysis

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:

胡士敏 

研究负责人:

段建钢 

Applicant:

Hu Shimin 

Study leader:

Duan Jiangang 

申请注册联系人电话:

Applicant telephone:

+86 186 1068 8524

研究负责人电话:

Study leader's telephone:

+86 10 8319 8302

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:

hushimin@xwhosp.org

研究负责人电子邮件:

Study leader's E-mail:

duanjiangang@xwhosp.org

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:

北京市西城区长椿街45号

研究负责人通讯地址:

北京市西城区长椿街45号

Applicant address:

No. 45 Changchun Street, Xicheng District, Beijing, China

Study leader's address:

No. 45 Changchun Street, Xicheng District, Beijing, China

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:

首都医科大学宣武医院

Applicant's institution:

Xuanwu Hospital, Capital Medical University

研究负责人所在单位:

首都医科大学宣武医院

Affiliation of the Leader:

Xuanwu Hospital, Capital Medical University

是否获伦理委员会批准:

是/Yes

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

临研审[2026]132号-002

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:

首都医科大学宣武医院伦理委员会-A

Name of the ethic committee:

Ethics Committee of Xuanwu Hospital Capital Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-04-25 00:00:00

伦理委员会联系人:

张卓然

Contact Name of the ethic committee:

Zhang Zhuoran

伦理委员会联系地址:

北京市西城区长椿街45号

Contact Address of the ethic committee:

No. 45 Changchun Street, Xicheng District, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 83199270

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xwzhuoranzhang@163.com

研究实施负责(组长)单位:

首都医科大学宣武医院

Primary sponsor:

Xuanwu Hospital, Capital Medical University

研究实施负责(组长)单位地址:

北京市西城区长椿街45号

Primary sponsor's address:

No. 45 Changchun Street, Xicheng District, Beijing, China

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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学宣武医院

具体地址:

北京市西城区长椿街45号

Institution
hospital:

Xuanwu Hospital, Capital Medical University

Address:

No. 45 Changchun Street, Xicheng District, Beijing, China

经费或物资来源:

首都卫生发展科研专项项目

Source(s) of funding:

Capital's Funds for Health Improvement and Research

Target disease:

Acute/subacute severe cerebral venous thrombosis

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

III期临床试验 

Study phase:

3

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

主要研究目标:评估在急性/亚急性重症颅内静脉血栓(CVT)患者中,当在住院期间给予激素联合规范化抗凝治疗时,其在90天有利的功能结局方面是否优于单纯规范化抗凝治疗。次要研究目标:评估激素联合规范化抗凝治疗与单纯规范化抗凝治疗在急性/亚急性CVT患者中安全性的差异。整合动态血清和脑脊液蛋白质组学技术,从分子层面阐明激素治疗改善预后的作用靶点,发现与治疗反应相关的关键蛋白及潜在生物标志物。  

Objectives of Study:

Primary study objective: To evaluate whether, in patients with acute/subacute severe cerebral venous thrombosis (CVT), the addition of corticosteroids to standardized anticoagulation therapy during hospitalization leads to a favorable functional outcome at 90 days, compared with standardized anticoagulation therapy alone.Secondary study objective: To evaluate the safety differences between standardized anticoagulation therapy plus corticosteroids and standardized anticoagulation therapy alone in patients with acute/subacute CVT. To integrate dynamic serum and cerebrospinal fluid proteomics techniques to elucidate, at the molecular level, the therapeutic targets by which corticosteroids improve prognosis, and to identify key proteins and potential biomarkers associated with treatment response.

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.由经验丰富的神经科医师依据临床表现、病史、体格检查及辅助检查结果综合判断,确立脑静脉血栓形成(CVT)诊断;其中影像学检查必须经常规磁共振成像(MRI)或磁共振黑血血栓成像(MRBTI)序列确认。
2.重症CVT患者(注:重症定义(满足任一条):存在静脉性脑梗死、脑出血、蛛网膜下腔出血、癫痫发作或意识障碍等并发症);
3.目前处于急性/亚急性期(注:急性/亚急性定义:发病至入院时间≤15天或症状加重至入院时间≤15天,且影像显示血栓符合急性/亚急性信号特征(T1/T2加权序列、增强MRI或MRBTI));
4.年龄在14-80岁之间;
5.性别不限;
6.同意参加研究并签署知情同意书。

Inclusion criteria

1. The diagnosis of cerebral venous thrombosis (CVT) is established by an experienced neurologist based on comprehensive assessment of clinical presentation, medical history, physical examination, and ancillary examination results; among which, imaging confirmation must be obtained by conventional magnetic resonance imaging (MRI) or magnetic resonance black-blood thrombus imaging (MRBTI) sequences; 2. Patients with severe CVT (Note: Severity is defined as meeting any one of the following criteria: presence of complications including venous cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, epileptic seizures, or impaired consciousness); 3. Currently in the acute/subacute phase (Note: Acute/subacute phase is defined as time from symptom onset to admission <=15 days, OR time from symptom worsening to admission ≤15 days, AND imaging shows thrombus signal characteristics consistent with acute/subacute stage on T1/T2-weighted sequences, contrast-enhanced MRI, or MRBTI); 4. Aged 14–80 years; 5. Both sexes; 6. Provide written informed consent to participate in the study.

排除标准:

1.年龄<14岁或外籍患者; 2.处于妊娠期或产后42天内的孕产妇; 3.合并1年内预后不良的各系统严重疾病如急性脑梗死、创伤性脑损伤、癌症、不稳定心绞痛、不能控制的哮喘等; 4.通过询问病史及入院后的检查结果诊断免疫相关疾病如Behcet's病、系统性红斑狼疮等; 5.处于结核进展期; 6.存在严重循环、呼吸、泌尿、消化以及造血系统疾病患者; 7.有激素使用绝对禁忌症的患者如不能控制的感染、严重糖尿病等; 8.发病前mRS≥3分; 9.生脑疝但拒绝去骨瓣减压术,或减压术后瞳孔对光反射未恢复。

Exclusion criteria:

1. Age <14 years or foreign patients; 2. Pregnant women or postpartum women within 42 days after delivery; 3. Presence of any severe systemic disease with poor prognosis within 1 year, such as acute cerebral infarction, traumatic brain injury, cancer, unstable angina, uncontrolled asthma, etc; 4. Diagnosis of immune-related diseases (e.g., Beh?et's disease, systemic lupus erythematosus, etc.) based on medical history and admission examination results; 5. Active progressive tuberculosis; 6. Patients with severe diseases of the circulatory, respiratory, urinary, digestive, or hematopoietic systems; 7. Absolute contraindications to corticosteroid use, such as uncontrolled infection, severe diabetes mellitus, etc; 8. Pre-onset modified Rankin Scale (mRS) score ≥3; 9. Cerebral herniation with refusal of decompressive craniectomy, or no recovery of pupillary light reflex after decompressive craniectomy.

研究实施时间:

Study execute time:

From 2026-01-01 00:00:00 To 2028-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-05-15 00:00:00 To 2028-09-30 00:00:00  

干预措施:

Interventions:

组别:

标准抗凝组

样本量:

155

Group:

Standard anticoagulation group

Sample size:

干预措施:

低分子肝素后桥接华法林等口服抗凝药

干预措施代码:

Intervention:

Low molecular weight heparin followed by bridging to warfarin or other oral anticoagulants.

Intervention code:

组别:

激素辅助标准抗凝组

样本量:

155

Group:

Corticosteroid?adjuvant plus standard anticoagulation group

Sample size:

干预措施:

甲泼尼龙琥珀酸钠静脉冲击及序贯减量治疗

干预措施代码:

Intervention:

Methylprednisolone pulse and sequential tapering therapy.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学宣武医院 

单位级别:

三级甲等 

Institution
hospital:

Xuanwu Hospital, Capital Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

陕西省 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

西安市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Xi'an Central Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

天津市 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学总医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Medical University General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京朝阳医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Chao-Yang Hospital, Capital Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

内蒙古自治区 

市(区县):

 

Country:

China 

Province:

Inner Mongolia Autonomous Region 

City:

 

单位(医院):

内蒙古民族大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Inner Mongolia Minzu University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Chengdu Second People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

湖北省第三人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Third People‘s Hospital Of Hubei Province

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

黑龙江省 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Harbin Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

天津市 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市环湖医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Huanhu Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Provincial People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital of Sichuan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

福建省 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Fujian Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

内蒙古自治区 

市(区县):

 

Country:

China 

Province:

Inner Mongolia Autonomous Region 

City:

 

单位(医院):

内蒙古医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Inner Mongolia Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学人民医院 

单位级别:

三级甲等 

Institution
hospital:

Renmin Hospital of Wuhan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属华山医院 

单位级别:

三级甲等 

Institution
hospital:

Huashan Hospital Affiliated to Fudan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山西省 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西医科大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Hospital of Shanxi Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

与激素相关不良事件的发生率

指标类型:

次要指标

Outcome:

Incidence of adverse events related to corticosteroid use

Type:

Secondary indicator

测量时间点:

入院14天,入院90天

测量方法:

监测是否出现新发下肢深静脉血栓、肺栓塞、胃/十二指肠溃疡、自发性骨折、骨坏死、感染及原有感染加重。在院期间直接通过病历记录采集,随访期通过电话随访采集。

Measure time point of outcome:

At day 14 and day 90 after admission

Measure method:

Monitor for new-onset deep vein thrombosis of the lower extremities, pulmonary embolism, gastric/duodenal ulcer, spontaneous fracture, osteonecrosis, infection, or worsening of pre-existing infection. Data will be collected directly from medical records during hospitalization, and via telephone follow-up during the follow-up period.

指标中文名:

美国国立卫生研究院卒中量表评分

指标类型:

次要指标

Outcome:

National Institutes of Health Stroke Scale (NIHSS) score

Type:

Secondary indicator

测量时间点:

基线(入院72内,干预前),入院14天

测量方法:

由经过培训的临床医生使用美国国立卫生研究院卒中量表(NIHSS)对患者的神经功能缺损严重程度进行量化评估。该量表的评分范围从0分(无神经功能缺损)到42分(最严重神经功能缺损),重点关注患者的意识水平、视觉功能、运动功能、感觉和忽视、共济失调、语言及构音障碍等核心神经功能领域。

Measure time point of outcome:

Baseline (within 72 hours of admission, before intervention), and day 14 after admission

Measure method:

A trained clinician quantifies the severity of the patient's neurological deficit using the National Institutes of Health Stroke Scale (NIHSS). The scale ranges from 0 (no neurological deficit) to 42 (most severe neurological deficit), with a focus on core neurological domains such as level of consciousness, visual function, motor function, sensation and neglect, ataxia, language, and dysarthria.

指标中文名:

脑静脉血栓复发

指标类型:

次要指标

Outcome:

Recurrence of cerebral venous thrombosis

Type:

Secondary indicator

测量时间点:

入院14天,入院90天

测量方法:

住院治疗期间及随访期新出现的头痛、头晕、恶心、呕吐症状,且影像学确认有发现新发脑静脉血栓形成;如果没有任何新发症状,视为阴性。

Measure time point of outcome:

At day 14 and day 90 after admission

Measure method:

Recurrence of CVT is defined as: new-onset headache, dizziness, nausea, or vomiting occurring during the hospital stay or follow-up period, with imaging evidence of new cerebral venous thrombosis. In the absence of any new symptoms, recurrence is considered negative.

指标中文名:

良好功能预后(定义为改良Rankin量表评分,mRS在0到2分)比例

指标类型:

主要指标

Outcome:

Proportion of good functional outcome (defined as a modified Rankin Scale [mRS] score of 0–2).

Type:

Primary indicator

测量时间点:

入院90天(±14天)

测量方法:

由经过培训的临床医生使用改良Rankin量表(mRS)对患者的整体功能独立性和残疾水平进行评估。该量表的评分范围从0分(完全无症状)到6分(死亡),重点关注患者进行日常活动的能力。进行统计时,将mRS评分转换为2分类变量,即0到2分为一组,3到6分为一组。

Measure time point of outcome:

90 days (+/-14 days) after admission

Measure method:

A trained clinician assesses the patient's overall functional independence and level of disability using the modified Rankin Scale (mRS). The scale ranges from 0 (no symptoms at all) to 6 (death), with a focus on the patient's ability to perform activities of daily living. For statistical analysis, the mRS score was converted into a binary variable, with scores 0–2 grouped together and scores 3–6 grouped together.

指标中文名:

血清和脑脊液蛋白质组学动态变化

指标类型:

次要指标

Outcome:

Dynamic changes in serum and cerebrospinal fluid proteomics

Type:

Secondary indicator

测量时间点:

基线(入院72小时内,干预前)和治疗后14天

测量方法:

采用液相色谱-串联质谱(LC-MS/MS)进行非标记定量蛋白质组学检测,分析差异表达蛋白及信号通路(重点:NLRP3/NETosis通路),并筛选与90天功能预后相关的潜在生物标志物。

Measure time point of outcome:

Baseline (within 72 hours of admission, before intervention) and day 14 after treatment

Measure method:

Label?free quantitative proteomics using liquid chromatography?tandem mass spectrometry (LC?MS/MS) to analyze differentially expressed proteins and signaling pathways (with a focus on the NLRP3/NETosis pathway), and to identify potential biomarkers associated with 90?day functional outcome.

指标中文名:

全因死亡发生率

指标类型:

次要指标

Outcome:

All-cause mortality rate

Type:

Secondary indicator

测量时间点:

入院14天,入院90天

测量方法:

随机分组后90天(±14天)观察窗内,任何原因导致的死亡事件的发生率。在院期间直接通过病历记录采集,随访期通过电话随访采集。

Measure time point of outcome:

At day 14 and day 90 after admission

Measure method:

The incidence of death from any cause occurring within the 90-day (±14-day) observation window after randomization. Data will be collected directly from medical records during hospitalization, and via telephone follow-up during the follow-up period.

指标中文名:

改良Rankin量表评分(mRS评分)

指标类型:

次要指标

Outcome:

A modified Rankin Scale (mRS) score

Type:

Secondary indicator

测量时间点:

基线(入院72内,干预前),入院14天,入院90天

测量方法:

由经过培训的临床医生使用改良Rankin量表(mRS)对患者的整体功能独立性和残疾水平进行评估。该量表的评分范围从0分(完全无症状)到6分(死亡),重点关注患者进行日常活动的能力。与主要疗效指标不同之处,在于测量时间点包含基线和入院14天,且统计时,mRS作为原始分、随访相较于基线的差值,以及mRS原始分以1分、3分作为分界点进行二分类处理。

Measure time point of outcome:

Baseline (within 72 hours of admission, pre?intervention), day 14 and 90 after admission

Measure method:

A trained clinician assesses the patient's overall functional independence and level of disability using the modified Rankin Scale (mRS). The scale ranges from 0 (no symptoms at all) to 6 (death), with a focus on the patient's ability to perform activities of daily living. The difference from the primary efficacy endpoint is that the measurement time points include baseline and day 14 after admission, and in the statistical analysis, the raw mRS score, the difference between follow?up and baseli

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血清

组织:

Sample Name:

Serum

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:

脑脊液

组织:

Sample Name:

Cerebrospinal fluid

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 14 years
最大 Max age 80 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):

合作方北京大学数据平台通过中央交互式网页响应系统(Interactive Web Response System)产生动态随机数列,采用最小化分层随机方法,在各中心内部、以及以下基线因素的各类别中实现两组间的平衡:基线mRS评分(1-2或3-5)。

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

The collaborating Peking University data platform will generate a dynamic randomization sequence using an Interactive Web Response System (IWRS). A minimization stratified randomization method will be employed to achieve balance between the two groups within each center and across the following categories of baseline factors: baseline mRS score (1-2 or 3-5).

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:

开放标签,对评估者设盲

Blinding:

Open-label study with blinded-evaluators

是否共享原始数据:

IPD sharing

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):

不共享

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

No sharing of raw data.

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:

数据通过专用电子数据采集系统,采用电子病例报告表(eCRF)进行采集。所有数据由研究中心研究者录入,原始数据来源于病历记录。eCRF访问采用密码保护,系统记录录入人员身份及时间。合同研究组织定期进行数据核查,确保数据的准确性、完整性和可靠性。患者隐私采用唯一识别编码进行保护,所有数据均去标识化处理。源文件及试验相关资料按照ICH-GCP及当地法规要求保存。

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

Data are collected using electronic case report forms (eCRFs) via a dedicated electronic data capture system. All data are sourced from original medical records and entered by site investigators. Access to the eCRF is password-protected, and the system records user identity and time of each entry. Data queries and verification are performed regularly by a contract research organization to ensure accuracy and completeness. Patient privacy is protected by using unique identification codes, and all data are de-identified. Source documents and trial-related records are retained in accordance with ICH-GCP and local regulations.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-05-11 17:57:29