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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2600124390 |
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最近更新日期: Date of Last Refreshed on: |
2026-05-11 17:57:29 |
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注册时间: Date of Registration: |
2026-05-11 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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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 |
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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 |
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注册题目简写: |
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English Acronym: |
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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 |
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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 |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
胡士敏 |
研究负责人: |
段建钢 |
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Applicant: |
Hu Shimin |
Study leader: |
Duan Jiangang |
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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 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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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 |
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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): |
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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 |
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Applicant address: |
No. 45 Changchun Street, Xicheng District, Beijing, China |
Study leader's address: |
No. 45 Changchun Street, Xicheng District, Beijing, China |
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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: |
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申请人所在单位: |
首都医科大学宣武医院 |
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Applicant's institution: |
Xuanwu Hospital, Capital Medical University |
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研究负责人所在单位: |
首都医科大学宣武医院 |
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Affiliation of the Leader: |
Xuanwu Hospital, Capital Medical University |
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是否获伦理委员会批准: |
是/Yes |
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Approved by ethic committee: |
Yes |
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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 |
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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 |
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Name of the ethic committee: |
Ethics Committee of Xuanwu Hospital Capital Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-04-25 00:00:00 |
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伦理委员会联系人: |
张卓然 |
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Contact Name of the ethic committee: |
Zhang Zhuoran |
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伦理委员会联系地址: |
北京市西城区长椿街45号 |
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Contact Address of the ethic committee: |
No. 45 Changchun Street, Xicheng District, Beijing, China |
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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 |
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研究实施负责(组长)单位: |
首都医科大学宣武医院 |
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Primary sponsor: |
Xuanwu Hospital, Capital Medical University |
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研究实施负责(组长)单位地址: |
北京市西城区长椿街45号 |
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Primary sponsor's address: |
No. 45 Changchun Street, Xicheng District, Beijing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
首都卫生发展科研专项项目 |
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Source(s) of funding: |
Capital's Funds for Health Improvement and Research |
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Target disease: |
Acute/subacute severe cerebral venous thrombosis |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
III期临床试验 | ||||||||||||||||||||||
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Study phase: |
3 |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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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。 |
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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. |
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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。 |
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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. |
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研究实施时间: Study execute time: |
从 From 2026-01-01 00:00:00至 To 2028-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从From 2026-05-15 00:00:00 至 To 2028-09-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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)。 |
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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). |
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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 |
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盲法: |
开放标签,对评估者设盲 |
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Blinding: |
Open-label study with blinded-evaluators |
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是否共享原始数据: IPD sharing |
No |
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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 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
No sharing of raw data. |
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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。 |
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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. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |