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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

1 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

392

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Ping Hu, MD
  • Número de telefone: +86 13097286794
  • E-mail: hp666edu@163.com

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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%.
Procedimento: 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.
Procedimento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of participants with mRS score 0-3 at 180 days after onset
Prazo: 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 resultados secundários

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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
All-cause mortality at 180 days after onset
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2029

Conclusão do estudo (Estimado)

1 de outubro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

16 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de junho de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de setembro de 2026

Última verificação

1 de março de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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