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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

3. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

392

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedure: 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.
Eksperimentel: 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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with mRS score 0-3 at 180 days after onset
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tidsramme
All-cause mortality at 90 days and 180 days
Tidsramme: 90 days, 180 days after onset
90 days, 180 days after onset
Incidence of bacterial ventriculitis or meningitis
Tidsramme: During treatment and 180-day follow-up
During treatment and 180-day follow-up
Incidence of cerebral hernia
Tidsramme: Perioperative period
Perioperative period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital of Nanchang University

Samarbejdspartnere

Shanghai Jiao Tong University School of Medicine

Efterforskere

  • Studiestol: Xingen Zhu, Prof, Second Affiliated Hospital of Nanchang University
  • Ledende efterforsker: Shigang Lv, MD, Second Affiliated Hospital of Nanchang University
  • Ledende efterforsker: Miaojing Wu, MD, Second Affiliated Hospital of Nanchang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. oktober 2029

Studieafslutning (Anslået)

1. oktober 2029

Datoer for studieregistrering

Først indsendt

16. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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