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<p>Over half of patients with intraventricular hemorrhage (IVH) die or develop severe disability, with fibrinolytic therapy via external ventricular drainage (EVD) showing limited efficacy for distal clot clearance and disappointing functional outcomes. The objective of this study was to evaluate a novel approach of simultaneous recombinant tissue plasminogen activator (rt-PA) administration through combined EVD and lumbar drainage (LD) catheters to improve IVH clearance and functional outcomes. A single-arm pilot study enrolled 20 adults with IVH from April 2021 to June 2022. Participants received&#xa0;simultaneous intrathecal rt-PA administered at a dose of 0.5&#xa0;mg per EVD and LD catheter every 12&#xa0;h,&#xa0;delivering a total of 1–1.5&#xa0;mg per treatment cycle based on catheter configuration.&#xa0;Following two complete cycles, mandatory cranial CT was performed to assess hematoma clearance and guide continuation decisions to a maximum of five cycles. The primary outcome was functional independence defined as a modified Rankin scale (mRS) score of 0–2 at 180&#xa0;days, assessed by neurologists blinded to treatment details. Results were compared to the historical matched controls (n = 246) from CLEAR III receiving EVD-alone rt-PA. At 180-day follow-up, nine of 20 patients (45%) achieved functional independence compared to 59 of 246 controls (24%) (P = 0.036). Two patients (10%) experienced rebleeding within 72&#xa0;h, ventriculitis occurred in zero patients (0%), and shunt dependence developed in three survivors (15%). Three-year mortality was 39% in 18 patients, with half of survivors maintaining functional independence. The findings of this pilot study provide preliminary evidence that the dual-catheter rt-PA strategy appears to be safe and feasible in intraventricular hemorrhage. These results must be carefully interpreted and validated in a future randomized controlled trial. Chinese Clinical Trail Registry (<a href="https://www.chictr.org.cn">https://www.chictr.org.cn</a>) ChiCTR2300070197. Retrospectively registered on April 4, 2023. First patient enrolled on August 31, 2021.</p>

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Safety and feasibility of dual external ventricular and lumbar drainage with rt-PA in intraventricular hemorrhage: A pilot study

  • 期刊论文

  • 发表日期：

    2026年2月11日

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  • Ping Hu,
  • Yifan Wang,
  • Senlin Du,
  • Ling Liu,
  • Junyong Yang,
  • Yanze Wu,
  • Tengfeng Yan,
  • Xinlei Yang,
  • Bing Xiao,
  • Minhua Ye,
  • Xingen Zhu,
  • Zhangsheng Yu,
  • Yanyan Gong,
  • Miaojing Wu

摘要

Over half of patients with intraventricular hemorrhage (IVH) die or develop severe disability, with fibrinolytic therapy via external ventricular drainage (EVD) showing limited efficacy for distal clot clearance and disappointing functional outcomes. The objective of this study was to evaluate a novel approach of simultaneous recombinant tissue plasminogen activator (rt-PA) administration through combined EVD and lumbar drainage (LD) catheters to improve IVH clearance and functional outcomes. A single-arm pilot study enrolled 20 adults with IVH from April 2021 to June 2022. Participants received simultaneous intrathecal rt-PA administered at a dose of 0.5 mg per EVD and LD catheter every 12 h, delivering a total of 1–1.5 mg per treatment cycle based on catheter configuration. Following two complete cycles, mandatory cranial CT was performed to assess hematoma clearance and guide continuation decisions to a maximum of five cycles. The primary outcome was functional independence defined as a modified Rankin scale (mRS) score of 0–2 at 180 days, assessed by neurologists blinded to treatment details. Results were compared to the historical matched controls (n = 246) from CLEAR III receiving EVD-alone rt-PA. At 180-day follow-up, nine of 20 patients (45%) achieved functional independence compared to 59 of 246 controls (24%) (P = 0.036). Two patients (10%) experienced rebleeding within 72 h, ventriculitis occurred in zero patients (0%), and shunt dependence developed in three survivors (15%). Three-year mortality was 39% in 18 patients, with half of survivors maintaining functional independence. The findings of this pilot study provide preliminary evidence that the dual-catheter rt-PA strategy appears to be safe and feasible in intraventricular hemorrhage. These results must be carefully interpreted and validated in a future randomized controlled trial. Chinese Clinical Trail Registry (https://www.chictr.org.cn) ChiCTR2300070197. Retrospectively registered on April 4, 2023. First patient enrolled on August 31, 2021.