Clinical trial Recruiting at 25 sites Phase 4 Interventional Ages 18 and up

Combining lumbar drainage with urokinase for treating severe aneurysmal subarachnoid hemorrhage

Official title: Effectiveness and Safety of Early Lumbar Drainage Plus Intrathecal Urokinase Injection in the Treatment of Severe Aneurysmal Subarachnoid Hemorrhage (LD-ITUK): a Multicentral Randomized Control Trial

Run by Second Affiliated Hospital of Nanchang University · NCT06284642 · Data updated 2026-11-12

This study is testing if a combination of spinal drainage and a special medication can help people with severe brain bleeding recover better than those who don’t receive the treatment.

More Aneurysmal Subarachnoid Hemorrhage trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment424 (estimated)
SponsorSecond Affiliated Hospital of Nanchang University
Academic / other
Locations25 sites (Hefei, Anhui and 24 other locations)
StatusRecruiting
StartedMarch 28, 2024
Main results expectedJune 30, 2027
Study endsDecember 30, 2027
Registry record updatedMay 5, 2026
Trial IDNCT06284642 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older experiencing their first occurrence of severe aneurysmal subarachnoid hemorrhage without prior craniotomy.

Probably not a fit

Patients with subarachnoid hemorrhage from other causes, those requiring craniotomy, or with serious comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of early lumbar drainage combined with intrathecal urokinase injection in patients with severe aneurysmal subarachnoid hemorrhage (aSAH). Eligible participants will be randomly assigned to receive either the treatment or a placebo, with the primary goal of assessing functional outcomes at six months post-treatment. The study aims to determine if this combined approach can improve neurological prognosis by facilitating the clearance of subarachnoid clots, which are known to contribute to complications like cerebral vasospasm. The trial is multicenter and employs a double-blind, placebo-controlled design to ensure robust results.

Why it matters

Potential benefit: If successful, this approach could significantly improve neurological outcomes and quality of life for patients suffering from severe aSAH.

How similar studies have gone: Previous studies have suggested that early drainage of cerebrospinal fluid can improve outcomes in aSAH, indicating potential success for this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Anhui Provincial Hospital
    Hefei, Anhui, China
    Recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Heihe, Anhui, China
    Recruiting
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian, China
    Recruiting
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong, China
    Recruiting
  • The First Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang, China
    Recruiting
  • Henan Provincial People's Hospital
    Zhengzhou, Henan, China
    Recruiting
Show 19 more locations
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
    Recruiting
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei, China
    Recruiting
  • Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
  • Union hospital,Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei, China
    Recruiting
  • Xiangya Hospital of Central South University
    Changsha, Hunan, China
    Recruiting
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu, China
    Recruiting
  • The first affiliated hospital of nanjing medical university
    Nanjing, Jiangsu, China
    Recruiting
  • 904th Hospital of Joint Logistic Support Force of PLA
    Wuxi, Jiangsu, China
    Recruiting
  • First Affiliated Hospital of Gannan Medical University
    Ganzhou, Jiangxi, China
    Recruiting
  • Ganzhou People's Hospital
    Ganzhou, Jiangxi, China
    Recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    Recruiting
  • Qilu hospital of shandong university
    Jinan, Shandong, China
    Recruiting
  • The First Affiliated Hospital of Shandong First Medical University
    Jinan, Shandong, China
    Recruiting
  • Changhai Hospital, Naval Medical University
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Huashan hospital of fudan university
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan, China
    Recruiting
  • First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

  • Principal investigator: Xingen Zhu, MS — Second Affiliated Hospital of Nanchang University
  • Study coordinator: Xingen Zhu, MS
  • Email: zxg2008vip@163.com
  • Phone: 13803546020

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.