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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

1 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

392

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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%.
Procedure: 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%.
Experimenteel: 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with mRS score 0-3 at 180 days after onset
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with mRS 0-3 at 90 days after onset
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From admission to hospital discharge
Total duration of hospitalization (days).
From admission to hospital discharge
Length of NICU stay
Tijdsspanne: 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
Tijdsspanne: From admission to hospital discharge
Total medical costs incurred during hospitalization, in RMB.
From admission to hospital discharge

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
All-cause mortality at 180 days after onset
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Second Affiliated Hospital of Nanchang University

Medewerkers

Shanghai Jiao Tong University School of Medicine

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2029

Studie voltooiing (Geschat)

1 oktober 2029

Studieregistratiedata

Eerst ingediend

16 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LD-IVH-2026-001
  • ChiCTR2600123877 (Register-ID: Chinese Clinical Trial Registry (ChiCTR))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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