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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

3. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

392

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Verfahren: 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.
Experimental: 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants with mRS score 0-3 at 180 days after onset
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Second Affiliated Hospital of Nanchang University

Mitarbeiter

Shanghai Jiao Tong University School of Medicine

Ermittler

  • Studienstuhl: Xingen Zhu, Prof, Second Affiliated Hospital of Nanchang University
  • Hauptermittler: Shigang Lv, MD, Second Affiliated Hospital of Nanchang University
  • Hauptermittler: Miaojing Wu, MD, Second Affiliated Hospital of Nanchang University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2029

Studienabschluss (Geschätzt)

1. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

16. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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