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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

1 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

392

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Ping Hu, MD
  • Номер телефона: +86 13097286794
  • Электронная почта: hp666edu@163.com

Места учебы

  • Китай
      • Changde, Китай
        • Changde First People's Hospital
        • Контакт:
          • Changde First People's Hospital
          • Электронная почта: 936483206@qq.com
      • Dezhou, Китай
      • Dezhou, Китай
        • Qilu Hospital of Shandong University Dezhou Hospital
        • Контакт:
      • Ganzhou, Китай
        • The First Affiliated Hospital of Gannan Medical University
        • Контакт:
          • The First Affiliated Hospital of Gannan Medical University
          • Электронная почта: zzbbchina@126.com
      • Ganzhou, Китай
        • Ganzhou People's Hospital
        • Контакт:
      • Ganzhou, Китай
        • Ruijin People's Hospital
        • Контакт:
          • Manchang Liu
          • Номер телефона: +8615970036188
          • Электронная почта: 61730146@qq.com
      • Guiyang, Китай
        • The Affiliated Hospital of Guizhou Medical University
        • Контакт:
          • The Affiliated Hospital of Guizhou Medical University
          • Электронная почта: yhmed@163.com
      • Hangzhou, Китай
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Контакт:
          • The First Affiliated Hospital of Zhejiang University School of
          • Электронная почта: gujun66@163.com
      • Hefei, Китай
        • The First Affiliated Hospital of Anhui Medical University
        • Контакт:
          • The First Affiliated Hospital of Anhui Medical University
          • Электронная почта: chenjunhui101@163.com
      • Jingdezhen, Китай
        • Jingdezhen Second People's Hospital
        • Контакт:
          • Jingdezhen Second People's Hospital
          • Электронная почта: 280960834@qq.com
      • Jiujiang, Китай
        • Jiujiang First People's Hospital
        • Контакт:
          • Jiujiang First People's Hospital
          • Электронная почта: 40616665@qq.com
      • Jiujiang, Китай
        • The First People's Hospital of Xiushui County
        • Контакт:
          • The First People's Hospital of Xiushui County
          • Электронная почта: lhb1062@163.com
      • Ji’an, Китай
        • Ji'an Central People's Hospital
        • Контакт:
      • Lanzhou, Китай
        • The Second Hospital of Lanzhou University
        • Контакт:
      • Linyi, Китай
        • Linyi People's Hospital
        • Контакт:
      • Luzhou, Китай
        • The Affiliated Hospital of Southwest Medical University
        • Контакт:
          • The Affiliated Hospital of Southwest Medical University
          • Электронная почта: yhmed@163.com
      • Nanchang, Китай
        • Second Affiliated Hospital of Nanchang University
        • Контакт:
          • Ping Hu
          • Номер телефона: +8613097286794
          • Электронная почта: hp666edu@163.com
      • Nanchang, Китай
        • Nanchang Central Hospital
        • Контакт:
      • Panzhihua, Китай
        • Panzhihua Central Hospital
        • Контакт:
      • Shiyan, Китай
        • Taihe Hospital
        • Контакт:
      • Suzhou, Китай
        • The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
        • Контакт:
          • The 904th Hospital of the Joint Logistics Support Force of the
          • Электронная почта: chenjunhui1019@163.com
      • Wenzhou, Китай
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Контакт:
          • Hansong Sheng
          • Номер телефона: +8613587782218
          • Электронная почта: shs951052@163.com
      • Yichang, Китай
        • Yichang Central People's Hospital
        • Контакт:
          • Yichang Central People's Hospital
          • Электронная почта: onedy@sina.com
      • Yichun, Китай
        • Zhangshu People's Hospital
        • Контакт:
          • Zhangshu People's Hospital
          • Электронная почта: 33309779@qq.com
      • Yingtan, Китай
        • Yingtan People's Hospital
        • Контакт:
      • Zhangjiagang, Китай
        • Zhangjiagang First People's Hospital
        • Контакт:
      • Zhoukou, Китай
        • Zhoukou Central Hospital
        • Контакт:
          • Zhoukou Central Hospital
          • Электронная почта: 96978849@qq.com
      • Zunyi, Китай
        • Zunyi First People's Hospital
        • Контакт:
          • Zunyi First People's Hospital
          • Электронная почта: 136166618@qq.com
    • Jiangxi
      • Fuzhou, Jiangxi, Китай
        • Fuzhou First People's Hospital
        • Контакт:
    • Shandong
      • Jinan, Shandong, Китай
        • Jinan Central Hospital
        • Контакт:
          • Song Li
          • Номер телефона: +8618761196261
          • Электронная почта: doctorlisong@126.com
    • Zhejiang
      • Taizhou, Zhejiang, Китай
        • Taizhou Hospital of Zhejiang Province
        • Контакт:
          • Zhixin Zhao
          • Номер телефона: +8617280677109
          • Электронная почта: caiyj10982@enzemed.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 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%.
Процедура: 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%.
Экспериментальный: 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.
Процедура: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Proportion of participants with mRS score 0-3 at 180 days after onset
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Proportion of participants with mRS 0-3 at 90 days after onset
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From admission to hospital discharge
Total duration of hospitalization (days).
From admission to hospital discharge
Length of NICU stay
Временное ограничение: 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
Временное ограничение: From admission to hospital discharge
Total medical costs incurred during hospitalization, in RMB.
From admission to hospital discharge

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
All-cause mortality at 180 days after onset
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Second Affiliated Hospital of Nanchang University

Соавторы

Shanghai Jiao Tong University School of Medicine

Следователи

  • Главный следователь: Shigang Lv, MD, Second Affiliated Hospital of Nanchang University
  • Главный следователь: Miaojing Wu, MD, Second Affiliated Hospital of Nanchang University
  • Главный следователь: Zeguang Ren, Prof, Methodist Houston Sugar Land Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 октября 2026 г.

Первичное завершение (Оцененный)

1 октября 2029 г.

Завершение исследования (Оцененный)

1 октября 2029 г.

Даты регистрации исследования

Первый отправленный

16 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

3 июня 2026 г.

Первый опубликованный (Действительный)

4 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

1 сентября 2026 г.

Последняя проверка

1 марта 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • LD-IVH-2026-001
  • ChiCTR2600123877 (Идентификатор реестра: Chinese Clinical Trial Registry (ChiCTR))

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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