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

RecruitingPhase 4Ages 18 Years - anyAllSecond Affiliated Hospital of Nanchang University
NCT06284642 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient's age ≥ 18 years * First occurrence of aneurysmal subarachnoid hemorrhage * Patients without any craniotomy treatment before onset * Hunt-Hess grade III-V * mRS grade 0 or 1 before onset * Aneurysm treatment within 48 hours of onset * Informed consent given by the subject or guardian Exclusion Criteria: * Subarachnoid hemorrhage caused by arteriovenous malformation or moyamoya disease or other cerebrovascular disease * Patients requiring craniotomy to remove intracranial hematoma * modified Fisher Scale grade 0 * Prothrombin time (PT) and activated partial thromboplastin time (APTT) are greater than 2 times the extended range * Absolute contraindications for lumbar puncture (e.g., brain hernia, puncture site infection) * Patients with a life expectancy of less than 1 year due to other causes * Other concomitant serious diseases that are difficult to treat; * Pregnant woman * Patients who were known to be allergic to urokinase and excipients or had a history of severe allergy and were deemed unsuitable for inclusion by the investigators * Participated in another interventional clinical trial within 30 days before randomization * Other reasons deemed unsuitable for study participation by the investigator
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What it tests

  • Urokinase
  • Placebo
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Where

25 sites
Anhui Provincial Hospital
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Heihe, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Zhujiang Hospital of Southern Medical University
Guangzhou, China
The First Affiliated Hospital of Harbin Medical University
Harbin, China
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Renmin Hospital of Wuhan University
Wuhan, China

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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