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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

1 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

392

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ping Hu, MD
  • Número de teléfono: +86 13097286794
  • Correo electrónico: hp666edu@163.com

Ubicaciones de estudio

  • Porcelana
      • Changde, Porcelana
        • Changde First People's Hospital
        • Contacto:
      • Dezhou, Porcelana
      • Dezhou, Porcelana
        • Qilu Hospital of Shandong University Dezhou Hospital
        • Contacto:
      • Ganzhou, Porcelana
        • The First Affiliated Hospital of Gannan Medical University
        • Contacto:
          • The First Affiliated Hospital of Gannan Medical University
          • Correo electrónico: zzbbchina@126.com
      • Ganzhou, Porcelana
        • Ganzhou People's Hospital
        • Contacto:
      • Ganzhou, Porcelana
        • Ruijin People's Hospital
        • Contacto:
          • Manchang Liu
          • Número de teléfono: +8615970036188
          • Correo electrónico: 61730146@qq.com
      • Guiyang, Porcelana
        • The Affiliated Hospital of Guizhou Medical University
        • Contacto:
          • The Affiliated Hospital of Guizhou Medical University
          • Correo electrónico: yhmed@163.com
      • Hangzhou, Porcelana
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contacto:
          • The First Affiliated Hospital of Zhejiang University School of
          • Correo electrónico: gujun66@163.com
      • Hefei, Porcelana
        • The First Affiliated Hospital of Anhui Medical University
        • Contacto:
      • Jingdezhen, Porcelana
        • Jingdezhen Second People's Hospital
        • Contacto:
      • Jiujiang, Porcelana
        • Jiujiang First People's Hospital
        • Contacto:
      • Jiujiang, Porcelana
        • The First People's Hospital of Xiushui County
        • Contacto:
          • The First People's Hospital of Xiushui County
          • Correo electrónico: lhb1062@163.com
      • Ji’an, Porcelana
        • Ji'an Central People's Hospital
        • Contacto:
      • Lanzhou, Porcelana
        • The Second Hospital of Lanzhou University
        • Contacto:
      • Linyi, Porcelana
        • Linyi People's Hospital
        • Contacto:
      • Luzhou, Porcelana
        • The Affiliated Hospital of Southwest Medical University
        • Contacto:
          • The Affiliated Hospital of Southwest Medical University
          • Correo electrónico: yhmed@163.com
      • Nanchang, Porcelana
        • Second Affiliated Hospital of Nanchang University
        • Contacto:
          • Ping Hu
          • Número de teléfono: +8613097286794
          • Correo electrónico: hp666edu@163.com
      • Nanchang, Porcelana
        • Nanchang Central Hospital
        • Contacto:
      • Panzhihua, Porcelana
        • Panzhihua Central Hospital
        • Contacto:
      • Shiyan, Porcelana
        • Taihe Hospital
        • Contacto:
      • Suzhou, Porcelana
        • The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
        • Contacto:
      • Wenzhou, Porcelana
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contacto:
          • Hansong Sheng
          • Número de teléfono: +8613587782218
          • Correo electrónico: shs951052@163.com
      • Yichang, Porcelana
        • Yichang Central People's Hospital
        • Contacto:
          • Yichang Central People's Hospital
          • Correo electrónico: onedy@sina.com
      • Yichun, Porcelana
        • Zhangshu People's Hospital
        • Contacto:
      • Yingtan, Porcelana
        • Yingtan People's Hospital
        • Contacto:
      • Zhangjiagang, Porcelana
        • Zhangjiagang First People's Hospital
        • Contacto:
      • Zhoukou, Porcelana
        • Zhoukou Central Hospital
        • Contacto:
      • Zunyi, Porcelana
        • Zunyi First People's Hospital
        • Contacto:
    • Jiangxi
      • Fuzhou, Jiangxi, Porcelana
        • Fuzhou First People's Hospital
        • Contacto:
    • Shandong
      • Jinan, Shandong, Porcelana
        • Jinan Central Hospital
        • Contacto:
    • Zhejiang
      • Taizhou, Zhejiang, Porcelana
        • Taizhou Hospital of Zhejiang Province
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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%.
Procedimiento: 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%.
Experimental: 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.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of participants with mRS score 0-3 at 180 days after onset
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of participants with mRS 0-3 at 90 days after onset
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From admission to hospital discharge
Total duration of hospitalization (days).
From admission to hospital discharge
Length of NICU stay
Periodo de tiempo: 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
Periodo de tiempo: From admission to hospital discharge
Total medical costs incurred during hospitalization, in RMB.
From admission to hospital discharge

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
All-cause mortality at 180 days after onset
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Second Affiliated Hospital of Nanchang University

Colaboradores

Shanghai Jiao Tong University School of Medicine

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de octubre de 2029

Finalización del estudio (Estimado)

1 de octubre de 2029

Fechas de registro del estudio

Enviado por primera vez

16 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • LD-IVH-2026-001
  • ChiCTR2600123877 (Identificador de registro: Chinese Clinical Trial Registry (ChiCTR))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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