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Early Lumbar Drainage for Intraventricular Hemorrhage (LD-IVH)

2026年9月1日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

392

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Ping Hu, MD
  • 電話番号：+86 13097286794
  • メール：hp666edu@163.com

研究場所

  • 中国
      • Changde、中国
        • Changde First People's Hospital
        • コンタクト：
      • Dezhou、中国
      • Dezhou、中国
        • Qilu Hospital of Shandong University Dezhou Hospital
        • コンタクト：
      • Ganzhou、中国
        • The First Affiliated Hospital of Gannan Medical University
        • コンタクト：
          • The First Affiliated Hospital of Gannan Medical University
          • メール：zzbbchina@126.com
      • Ganzhou、中国
        • Ganzhou People's Hospital
        • コンタクト：
      • Ganzhou、中国
        • Ruijin People's Hospital
        • コンタクト：
      • Guiyang、中国
        • The Affiliated Hospital of Guizhou Medical University
        • コンタクト：
          • The Affiliated Hospital of Guizhou Medical University
          • メール：yhmed@163.com
      • Hangzhou、中国
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • コンタクト：
          • The First Affiliated Hospital of Zhejiang University School of
          • メール：gujun66@163.com
      • Hefei、中国
        • The First Affiliated Hospital of Anhui Medical University
        • コンタクト：
      • Jingdezhen、中国
        • Jingdezhen Second People's Hospital
        • コンタクト：
      • Jiujiang、中国
        • Jiujiang First People's Hospital
        • コンタクト：
      • Jiujiang、中国
        • The First People's Hospital of Xiushui County
        • コンタクト：
          • The First People's Hospital of Xiushui County
          • メール：lhb1062@163.com
      • Ji’an、中国
        • Ji'an Central People's Hospital
        • コンタクト：
      • Lanzhou、中国
        • The Second Hospital of Lanzhou University
        • コンタクト：
      • Linyi、中国
        • Linyi People's Hospital
        • コンタクト：
      • Luzhou、中国
        • The Affiliated Hospital of Southwest Medical University
        • コンタクト：
          • The Affiliated Hospital of Southwest Medical University
          • メール：yhmed@163.com
      • Nanchang、中国
        • Second Affiliated Hospital of Nanchang University
        • コンタクト：
      • Nanchang、中国
        • Nanchang Central Hospital
        • コンタクト：
      • Panzhihua、中国
        • Panzhihua Central Hospital
        • コンタクト：
      • Shiyan、中国
        • Taihe Hospital
        • コンタクト：
      • Suzhou、中国
        • The 904th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
        • コンタクト：
      • Wenzhou、中国
        • The Second Affiliated Hospital of Wenzhou Medical University
        • コンタクト：
      • Yichang、中国
        • Yichang Central People's Hospital
        • コンタクト：
      • Yichun、中国
        • Zhangshu People's Hospital
        • コンタクト：
      • Yingtan、中国
        • Yingtan People's Hospital
        • コンタクト：
      • Zhangjiagang、中国
        • Zhangjiagang First People's Hospital
        • コンタクト：
      • Zhoukou、中国
        • Zhoukou Central Hospital
        • コンタクト：
      • Zunyi、中国
        • Zunyi First People's Hospital
        • コンタクト：
    • Jiangxi
      • Fuzhou、Jiangxi、中国
        • Fuzhou First People's Hospital
        • コンタクト：
    • Shandong
      • Jinan、Shandong、中国
        • Jinan Central Hospital
        • コンタクト：
    • Zhejiang
      • Taizhou、Zhejiang、中国
        • Taizhou Hospital of Zhejiang Province
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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%.
手順：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%.
実験的：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.
手順：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Proportion of participants with mRS score 0-3 at 180 days after onset
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of participants with mRS 0-3 at 90 days after onset
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From admission to hospital discharge
Total duration of hospitalization (days).
From admission to hospital discharge
Length of NICU stay
時間枠：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
時間枠：From admission to hospital discharge
Total medical costs incurred during hospitalization, in RMB.
From admission to hospital discharge

その他の成果指標

結果測定
メジャーの説明
時間枠
All-cause mortality at 180 days after onset
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Second Affiliated Hospital of Nanchang University

協力者

Shanghai Jiao Tong University School of Medicine

捜査官

  • 主任研究者：Shigang Lv, MD、Second Affiliated Hospital of Nanchang University
  • 主任研究者：Miaojing Wu, MD、Second Affiliated Hospital of Nanchang University
  • 主任研究者：Zeguang Ren, Prof、Methodist Houston Sugar Land Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2029年10月1日

研究の完了 (推定)

2029年10月1日

試験登録日

最初に提出

2026年5月16日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月4日

QC基準を満たした最後の更新が送信されました

2026年9月1日

最終確認日

2026年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • LD-IVH-2026-001
  • ChiCTR2600123877 (レジストリ識別子：Chinese Clinical Trial Registry (ChiCTR))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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