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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

3 giugno 2026 aggiornato da: 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 comparing the addition of early lumbar drainage to standard care in patients with intraventricular hemorrhage (IVH) in China. The primary objective is to evaluate whether early lumbar drainage improves long-term functional outcomes at 180 days, as measured by the modified Rankin Scale (mRS), and reduces complications in patients treated with external ventricular drainage (EVD) and intrathecal urokinase.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 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.

This study uses a 1:1 stratified block randomization design, with stratification by the etiology of IVH, site of ventricular obstruction, and participating center. Eligible patients will be randomized to receive either:

Control group: Standard treatment with EVD plus daily intrathecal urokinase (30,000 IU) for up to 3 to 5 days.

Intervention group: The same standard EVD and urokinase regimen, plus early lumbar drainage initiated within 24 hours of EVD placement. Drainage will be titrated to a rate ≤8 mL/h, with a maximum daily volume of 200 mL, to maintain stable intracranial pressure.

The primary endpoint is the proportion of patients with a favorable functional outcome (mRS 0-3) at 180 days. Secondary endpoints include 90-day functional status, incidence of post-hemorrhagic hydrocephalus, hospital length of stay, and mortality. Safety endpoints include all-cause mortality, intracranial infection, and cerebral herniation. A total of 392 patients will be enrolled, with an interim efficacy analysis planned when 50% of participants complete their 180-day follow-up.

Tipo di studio

Interventistico

Iscrizione (Stimato)

392

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
      • Changde, Cina
        • Changde First People's Hospital
        • Contatto:
      • Dezhou, Cina
      • Dezhou, Cina
      • Ganzhou, Cina
        • The First Affiliated Hospital of Gannan Medical University
        • Contatto:
          • The First Affiliated Hospital of Gannan Medical University
          • Email: zzbbchina@126.com
      • Ganzhou, Cina
      • Ganzhou, Cina
        • Ruijin People's Hospital
        • Contatto:
      • Guiyang, Cina
        • The Affiliated Hospital of Guizhou Medical University
        • Contatto:
          • The Affiliated Hospital of Guizhou Medical University
          • Email: yhmed@163.com
      • Hangzhou, Cina
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contatto:
          • The First Affiliated Hospital of Zhejiang University School of
          • Email: gujun66@163.com
      • Hefei, Cina
        • The First Affiliated Hospital of Anhui Medical University
        • Contatto:
      • Jingdezhen, Cina
        • Jingdezhen Second People's Hospital
        • Contatto:
      • Jiujiang, Cina
        • Jiujiang First People's Hospital
        • Contatto:
      • Jiujiang, Cina
        • The First People's Hospital of Xiushui County
        • Contatto:
      • Ji’an, Cina
        • Ji'an Central People's Hospital
        • Contatto:
      • Lanzhou, Cina
        • The Second Hospital of Lanzhou University
        • Contatto:
      • Linyi, Cina
      • Luzhou, Cina
        • The affiliated hospital of Southwest Medical University
        • Contatto:
          • The Affiliated Hospital of Southwest Medical University
          • Email: yhmed@163.com
      • Nanchang, Cina
        • Second Affiliated Hospital of Nanchang University
        • Contatto:
          • Second Affiliated Hospital of Nanchang University
          • Numero di telefono: +86 13097286794
          • Email: hp666edu@163.com
      • Nanchang, Cina
        • Nanchang Central Hospital
        • Contatto:
      • Panzhihua, Cina
      • Shiyan, Cina
      • Suzhou, Cina
        • The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
        • Contatto:
      • Wenzhou, Cina
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contatto:
          • The Second Affiliated Hospital of Wenzhou Medical University
          • Email: shs951052@163.com
      • Yichang, Cina
        • Yichang Central People's Hospital
        • Contatto:
      • Yichun, Cina
        • Zhangshu People's Hospital
        • Contatto:
      • Yingtan, Cina
        • Yingtan People's Hospital
        • Contatto:
      • Zhangjiagang, Cina
        • Zhangjiagang First People's Hospital
        • Contatto:
      • Zhoukou, Cina
        • Zhoukou Central Hospital
        • Contatto:
      • Zunyi, Cina
        • Zunyi First People's Hospital
        • Contatto:
    • Jiangxi
      • Fuzhou, Jiangxi, Cina

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Aged 18 to 85 years old, no limitation on gender.
  • First-ever intracerebral hemorrhage confirmed by CT/MRI, accompanied by third and/or fourth intraventricular hemorrhage, requiring external ventricular drainage.
  • Baseline hemorrhage volume less than 30 mL, with stable clinical condition before randomization.
  • External ventricular drainage performed within 48 hours of symptom onset.
  • Randomization completed within 24 hours after EVD placement.
  • Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.
  • Written informed consent obtained from the participant or their legally authorized representative.

Exclusion Criteria:

  • Suspected or untreated ruptured intracranial aneurysm, arteriovenous malformation (AVM), or intracranial tumor, unless excluded by vascular imaging. Previously treated aneurysm or AVM must have been completed at least 3 months prior to enrollment.

  • Choroidal vascular malformation or moyamoya disease.

    • Long-term oral anticoagulant use, persistent coagulation dysfunction, or known allergy to urokinase.

  • Platelet count < 100×10⁹/L or INR > 1.4.
  • Absolute contraindications to lumbar cistern drainage or external ventricular drainage, such as cerebral hernia or infection at the puncture site.
  • Infratentorial hemorrhage volume ≥ 10 mL.
  • Thalamic hemorrhage ≥ 10 mL, or accompanied by midbrain extension, oculomotor nerve palsy, or fixed dilated pupil.
  • Hemiplegia with muscle strength grade 0 or 1.
  • Active bleeding in the gastrointestinal, genitourinary, or respiratory system.
  • Multiple ecchymoses or petechiae suggesting a bleeding tendency.
  • Expected survival time less than 6 months.
  • Severe, untreatable concomitant systemic diseases.
  • Pregnancy.
  • Participation in other interventional clinical trials within 30 days prior to randomization.
  • Any other condition deemed inappropriate for enrollment by the investigator(s).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control Group (EVD + Intrathecal Urokinase)
Patients receive external ventricular drainage combined with intrathecal urokinase injection. Single dose 30,000 IU per day for continuous 3 days, and the maximum duration of urokinase treatment shall not exceed 5 days. Discontinue medication when third/fourth ventricular clot clearance, relieved mass effect, or hematoma clearance rate ≥80% on cranial CT.
Procedura: External ventricular drainage plus Intrathecal Urokinase
Patients receive external ventricular drainage combined with intrathecal urokinase injection. Single dose 30,000 IU per day for continuous 3 days; the maximum duration of urokinase treatment shall not exceed 5 days. Discontinue medication when third/fourth ventricular clot clearance, relieved mass effect, or hematoma clearance rate ≥80% on cranial CT.
Sperimentale: Intervention Group (EVD + Urokinase + Early Lumbar Cistern Drainage)
On the basis of the same EVD and intrathecal urokinase regimen as the control group, early lumbar drainage is performed within 24 hours. CSF drainage speed is controlled below 8 mL/h, and daily total drainage volume does not exceed 200 mL to maintain stable intracranial pressure.
Procedura: Lumbar Drainage combined with external ventricular drainage plus Intrathecal Urokinase
Early lumbar cistern drainage is performed within 24 hours. CSF drainage speed is controlled below 8 mL/h, and daily total drainage volume does not exceed 200 mL to maintain stable intracranial pressure.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants with mRS score 0-3 at 180 days after onset
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Proportion of participants with mRS 0-3 at 90 days after onset
Lasso di tempo: 90 days after onset
90 days after onset
Proportion of participants with GOS score 4-5 at 180 days after onset
Lasso di tempo: 180 days after onset
180 days after onset
Proportion of participants with mRS 0-2 at 90 days and 180 days
Lasso di tempo: 90 days, 180 days after onset
90 days, 180 days after onset
Ordinal change of mRS score from baseline to 180 days
Lasso di tempo: Baseline to 180 days
Baseline to 180 days
EQ-5D health utility score at 180 days
Lasso di tempo: 180 days after onset
180 days after onset
Proportion of participants with Barthel index 75-100 at 180 days
Lasso di tempo: 180 days after onset
180 days after onset
Incidence of post-hemorrhagic hydrocephalus
Lasso di tempo: Up to 180 days after onset
Up to 180 days after onset
Length of hospital stay
Lasso di tempo: Perioperative period
Perioperative period
Total hospitalization cost
Lasso di tempo: Perioperative period
Perioperative period

Altre misure di risultato

Misura del risultato
Lasso di tempo
All-cause mortality at 90 days and 180 days
Lasso di tempo: 90 days, 180 days after onset
90 days, 180 days after onset
Incidence of bacterial ventriculitis or meningitis
Lasso di tempo: During treatment and 180-day follow-up
During treatment and 180-day follow-up
Incidence of cerebral hernia
Lasso di tempo: Perioperative period
Perioperative period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Second Affiliated Hospital of Nanchang University

Collaboratori

Shanghai Jiao Tong University School of Medicine

Investigatori

  • Cattedra di studio: Xingen Zhu, Prof, Second Affiliated Hospital of Nanchang University
  • Investigatore principale: Shigang Lv, MD, Second Affiliated Hospital of Nanchang University
  • Investigatore principale: Miaojing Wu, MD, Second Affiliated Hospital of Nanchang University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 ottobre 2029

Completamento dello studio (Stimato)

1 ottobre 2029

Date di iscrizione allo studio

Primo inviato

16 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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