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Early Lumbar Drainage Plus Intrathecal Urokinase in Severe Aneurysmal Subarachnoid Hemorrhage (LD-ITUK)

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Jan 30, 2026 to Jun 30, 2027v3 Show 4 more changesShow less
    • Study sites: 1 to 25
    • Study completion date: Jun 30, 2026 to Dec 30, 2027
    • Collaborators: 1 to 33
    • Study title shortened, about 3 words
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 30, 2025 to Jan 30, 2026
    • Start date changed from estimate of Mar 1, 2024 to Mar 28, 2024
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 10 to 13
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group. Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase, once a day for 3 consecutive days. Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo (0.9%NaCl) injection. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 2 on the modified Rankin Scale (mRS), at 6 months after aneurysmal SAH. Primary outcome will be determined by a member of the Independent Committee on Terminal events.
Trial Details
NCT Number NCT06284642
Lead Sponsor Second Affiliated Hospital of Nanchang University
Collaborators: First Affiliated Hospital of Fujian Medical University, Huashan Hospital, Henan Provincial People's Hospital, Tongji Hospital, Southern Medical University, China, Qilu Hospital of Shandong University, Sichuan Provincial People's Hospital, Zhongnan Hospital, Zhejiang University, The First Affiliated Hospital of Zhengzhou University, Xiangya Hospital of Central South University, First Affiliated Hospital of Gannan Medical University, Ganzhou City People's Hospital, The First Affiliated Hospital of Anhui Medical University, Renmin Hospital of Wuhan University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Yichang Central People's Hospital, Xianning Central Hospital, Linyi People's Hospital, Panzhihua Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Changhai Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital with Nanjing Medical University, 904th Hospital of the Joint Logistics Support Force of the PLA, Qianfoshan Hospital, Dezhou Hospital Qilu Hospital of Shandong University, Liaocheng People's Hospital, Xuanwu Hospital, Beijing, Jiujiang No.1 People's Hospital, The First People's Hospital of Changde City
Conditions
(from sponsor)		 Aneurysmal Subarachnoid Hemorrhage
Related terms Subarachnoid Hemorrhage
Enrollment 424 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov