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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

2026年9月1日 更新者：Second Affiliated Hospital of Nanchang University

Effectiveness and Safety of Early Lumbar Drainage in the Treatment of Ventricular Hemorrhage: the LD-IVH Randomized Controlled Trial

This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial in Chinese patients with intraventricular hemorrhage (IVH), comparing early lumbar drainage added to standard care with standard care alone. The primary objective is to evaluate whether, in patients treated with external ventricular drainage (EVD) and intrathecal urokinase, the addition of early lumbar drainage improves functional outcomes at 180 days, as measured by the modified Rankin Scale (mRS), and reduces complications.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Intraventricular hemorrhage (IVH) is a life-threatening complication of acute stroke, associated with high rates of mortality and severe disability, fewer than 20% of survivors achieve favorable functional outcomes. Despite the widespread use of external ventricular drainage (EVD) and intraventricular thrombolysis, the role of early lumbar drainage in improving outcomes remains controversial, with limited high-level evidence from randomized controlled trials.

The LD-IVH study will use a 1:1 stratified block randomization design, with stratification by intraparenchymal hematoma and hospital. Eligible patients will be randomized to receive either (1) control group treatment: standard EVD plus daily intrathecal urokinase (30,000 IU) for 3 consecutive days, with a maximum treatment duration of 5 days; or (2) intervention group treatment: the same EVD and intrathecal urokinase regimen as the control group, with early lumbar drainage additionally initiated within 72 hours of onset. CSF was drained at a rate of ≤8 mL/h, with a daily maximum volume of 200 mL, to keep intracranial pressure stable.

The primary endpoint will be the proportion of patients with a favorable functional outcome (modified Rankin Scale [mRS] score 0-3) at 180 days. A total of 392 patients will be enrolled, and an interim efficacy analysis is planned after 50% of participants complete the 180-day follow-up.

研究类型

介入性

注册 (估计的)

392

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Changde、中国
        • Changde First People's Hospital
        • 接触：
      • Dezhou、中国
      • Dezhou、中国
      • Ganzhou、中国
        • The First Affiliated Hospital of Gannan Medical University
        • 接触：
          • The First Affiliated Hospital of Gannan Medical University
          • 邮箱：zzbbchina@126.com
      • Ganzhou、中国
      • Ganzhou、中国
        • Ruijin People's Hospital
        • 接触：
      • Guiyang、中国
        • The Affiliated Hospital of Guizhou Medical University
        • 接触：
          • The Affiliated Hospital of Guizhou Medical University
          • 邮箱：yhmed@163.com
      • Hangzhou、中国
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • 接触：
          • The First Affiliated Hospital of Zhejiang University School of
          • 邮箱：gujun66@163.com
      • Hefei、中国
        • The First Affiliated Hospital of Anhui Medical University
        • 接触：
      • Jingdezhen、中国
        • Jingdezhen Second People's Hospital
        • 接触：
      • Jiujiang、中国
        • Jiujiang First People's Hospital
        • 接触：
      • Jiujiang、中国
        • The First People's Hospital of Xiushui County
        • 接触：
      • Ji’an、中国
        • Ji'an Central People's Hospital
        • 接触：
      • Lanzhou、中国
        • The Second Hospital of Lanzhou University
        • 接触：
      • Linyi、中国
        • Linyi People's Hospital
        • 接触：
      • Luzhou、中国
        • The Affiliated Hospital of Southwest Medical University
        • 接触：
          • The Affiliated Hospital of Southwest Medical University
          • 邮箱：yhmed@163.com
      • Nanchang、中国
        • Second Affiliated Hospital of Nanchang University
        • 接触：
      • Nanchang、中国
        • Nanchang Central Hospital
        • 接触：
      • Panzhihua、中国
      • Shiyan、中国
      • Suzhou、中国
        • The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
        • 接触：
      • Wenzhou、中国
        • The Second Affiliated Hospital of Wenzhou Medical University
        • 接触：
      • Yichang、中国
        • Yichang Central People's Hospital
        • 接触：
      • Yichun、中国
        • Zhangshu People's Hospital
        • 接触：
      • Yingtan、中国
        • Yingtan People's Hospital
        • 接触：
      • Zhangjiagang、中国
        • Zhangjiagang First People's Hospital
        • 接触：
      • Zhoukou、中国
        • Zhoukou Central Hospital
        • 接触：
      • Zunyi、中国
        • Zunyi First People's Hospital
        • 接触：
    • Jiangxi
      • Fuzhou、Jiangxi、中国
    • Shandong
      • Jinan、Shandong、中国
        • Jinan Central Hospital
        • 接触：
    • Zhejiang
      • Taizhou、Zhejiang、中国
        • Taizhou Hospital of Zhejiang Province
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Aged 18-85 years, of either sex.
  2. First-ever intracerebral hemorrhage (ICH) with CT-confirmed hemorrhage involving the third and/or fourth ventricle, and scheduled to undergo or already having undergone burr-hole ventricular drainage.
  3. Intraparenchymal hemorrhage volume <30 mL on admission CT, with stable neurological status and no progressive deterioration before randomization.
  4. Randomization completed within 72 hours of symptom onset.
  5. Pre-onset modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (minor symptoms not interfering with daily activities).
  6. Written informed consent obtained from the participant or a legal guardian.

Exclusion Criteria:

  1. Secondary intracerebral hemorrhage, including imaging-confirmed untreated intracranial arteriovenous malformation (AVM), ruptured intracranial aneurysm, moyamoya disease, or intracranial tumor.
  2. Long-term use of anticoagulant medication, persistent coagulopathy, or known allergy to urokinase.
  3. Prothrombin time (PT) or activated partial thromboplastin time (APTT) prolonged to more than twice the upper limit of normal.
  4. Absolute contraindications to lumbar or external ventricular drainage (e.g., cerebral herniation, infection at the puncture site).
  5. Infratentorial hemorrhage with a volume ≥10 mL.
  6. Thalamic hemorrhage with a volume ≥10 mL, or accompanied by obvious extension into the midbrain, oculomotor nerve palsy, or fixed and dilated non-reactive pupils.
  7. Unilateral limb paralysis (muscle strength grade 0 or 1) before randomization.
  8. Active bleeding from other sites, including the gastrointestinal, genitourinary, or respiratory tracts.
  9. Multiple superficial ecchymoses, purpura, or other signs suggesting bleeding or a bleeding tendency.
  10. Expected survival of less than 6 months due to other causes.
  11. Other coexisting severe diseases that are difficult to treat.
  12. Pregnancy.
  13. Participation in another interventional clinical trial within 30 days before randomization.
  14. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control Group (EVD + Intrathecal Urokinase)
Patients received external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase was administered as a single daily dose of 30,000 IU for 3 consecutive days. A follow-up cranial CT was then performed to assess ventricular obstruction and hematoma clearance, which guided the decision on whether to continue thrombolysis. The maximum total duration of urokinase treatment did not exceed 5 days. Thrombolysis was discontinued when CT demonstrated clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%.
程序：Control treatment schedule
Patients receive external ventricular drainage (EVD) combined with intrathecal urokinase injection. Urokinase is administered as a single daily dose of 30,000 IU for 3 consecutive days, and the maximum duration of urokinase treatment does not exceed 5 days. Thrombolysis is discontinued when cranial CT demonstrates clearance of the third/fourth ventricular cast, relief of mass effect, or a hematoma clearance rate of ≥80%.
实验性的：Intervention Group (Control Treatment + Lumbar Drainage)
In addition to the same EVD and intrathecal urokinase regimen as the control group, early lumbar drainage was initiated within 72 hours of onset. The CSF drainage rate was maintained below 8 mL/h, and the daily total drainage volume did not exceed 200 mL to maintain stable intracranial pressure.
程序：Control treatment plus lumbar drainage
Early lumbar cistern drainage was initiated within 72 hours of onset. The CSF drainage rate was maintained below 8 mL/h, and the daily total drainage volume did not exceed 200 mL to maintain stable intracranial pressure.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants with mRS score 0-3 at 180 days after onset
大体时间：180 days after disease onset
Percentage of patients with modified Rankin Scale score 0 to 3 at 180-day follow-up.
180 days after disease onset

次要结果测量

结果测量
措施说明
大体时间
Proportion of participants with mRS 0-3 at 90 days after onset
大体时间：90 days after onset
Percentage of patients with a modified Rankin Scale score of 0 to 3 at the 90-day follow-up.
90 days after onset
Proportion of participants with GOS score 4-5 at 180 days after onset
大体时间：180 days after onset
Percentage of patients with a Glasgow Outcome Scale (GOS) score of 4 or 5 at the 180-day follow-up.
180 days after onset
Proportion of participants with mRS 0-2 at 90 days and 180 days
大体时间：90 and 180 days after disease onset
Percentage of patients with a modified Rankin Scale score of 0 to 2 at the 90- and 180-day follow-up.
90 and 180 days after disease onset
Change in ordinal mRS score from baseline to 180 days after onset
大体时间：Baseline to 180 days after disease onset
Change in the ordinal modified Rankin Scale score between baseline and the 180-day follow-up.
Baseline to 180 days after disease onset
EQ-5D score at 180 days after onset
大体时间：180 days after disease onset
Health-related quality of life measured by the EuroQol-5D (EQ-5D) questionnaire at the 180-day follow-up.
180 days after disease onset
Proportion of participants with Barthel Index score 75-100 at 180 days after onset
大体时间：180 days after disease onset
Percentage of patients with a Barthel Index score of 75 to 100 at the 180-day follow-up.
180 days after disease onset
Proportion of participants with shunt-dependent hydrocephalus before discharge and at 180 days after onset
大体时间：Before hospital discharge and 180 days after disease onset
Percentage of patients requiring permanent cerebrospinal fluid shunting for hydrocephalus before hospital discharge and at the 180-day follow-up.
Before hospital discharge and 180 days after disease onset
Daily CSF drainage volume before catheter removal
大体时间：During the drainage period before catheter removal
Daily volume of cerebrospinal fluid drained (mL/day) from the external ventricular drain and lumbar drain before removal of the drainage catheters.
During the drainage period before catheter removal
Proportion of participants with resolution of third and/or fourth ventricular obstruction
大体时间：Within 14 days after enrollment or before hospital discharge
Percentage of patients with resolution of third and/or fourth ventricular obstruction on cranial CT within 14 days after enrollment or before hospital discharge.
Within 14 days after enrollment or before hospital discharge
Dynamic intracranial hemorrhage clearance rate before catheter removal
大体时间：Before removal of the external ventricular and lumbar drainage catheters
Serial (dynamic) rate of intracranial hemorrhage clearance on cranial CT before removal of the external ventricular and lumbar drainage catheters.
Before removal of the external ventricular and lumbar drainage catheters
Length of hospital stay
大体时间：From admission to hospital discharge
Total duration of hospitalization (days).
From admission to hospital discharge
Length of NICU stay
大体时间：From NICU admission to NICU discharge
Total duration of stay in the intensive care unit (days).
From NICU admission to NICU discharge
Total hospitalization costs
大体时间：From admission to hospital discharge
Total medical costs incurred during hospitalization, in RMB.
From admission to hospital discharge

其他结果措施

结果测量
措施说明
大体时间
All-cause mortality at 180 days after onset
大体时间：180 days after disease onset
Percentage of patients who died from any cause by the 180-day follow-up.
180 days after disease onset
Proportion of participants with intracranial infection
大体时间：From enrollment through hospital discharge
Percentage of patients who developed intracranial infection during the study period.
From enrollment through hospital discharge
Proportion of participants with cerebral herniation
大体时间：From enrollment through hospital discharge
Percentage of patients who developed cerebral herniation.
From enrollment through hospital discharge
Proportion of participants with symptomatic rebleeding within 72 hours after catheter placement or thrombolysis
大体时间：Within 72 hours after catheter placement or thrombolysis
Percentage of patients with symptomatic intracranial rebleeding within 72 hours after catheter placement or intrathecal thrombolysis.
Within 72 hours after catheter placement or thrombolysis
Proportion of participants with other serious adverse events
大体时间：From enrollment through the 180-day follow-up
Percentage of patients who experienced other serious adverse events during the study period.
From enrollment through the 180-day follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Second Affiliated Hospital of Nanchang University

合作者

Shanghai Jiao Tong University School of Medicine

调查人员

  • 首席研究员：Shigang Lv, MD、Second Affiliated Hospital of Nanchang University
  • 首席研究员：Miaojing Wu, MD、Second Affiliated Hospital of Nanchang University
  • 首席研究员：Zeguang Ren, Prof、Methodist Houston Sugar Land Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2029年10月1日

研究完成 (估计的)

2029年10月1日

研究注册日期

首次提交

2026年5月16日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LD-IVH-2026-001
  • ChiCTR2600123877 (注册表标识符：Chinese Clinical Trial Registry (ChiCTR))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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