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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 424 (estimated) |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 25 sites (Hefei, Anhui and 24 other locations) |
| Status | Recruiting |
| Started | March 28, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06284642 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
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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
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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.
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Nitric Oxide Use to Predict Vasospasm in Aneurysmal Subarachnoid Hemorrhage
This study tests whether nitric oxide consumption in CSF can predict cerebral vasospasm in patients with aneurysmal SAH.
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Multi-omics program to understand complications and outcomes after aneurysmal subarachnoid hemorrhage
This project will test if combining blood, cerebrospinal fluid, urine, imaging, and multi-omics data can find biomarkers that predict complications and outcomes in adults with aneurysmal subarachnoid hemorrhage.
-
Dome-only coiling for severe aneurysmal subarachnoid hemorrhage
This will test a minimally invasive dome-protection coiling procedure to prevent re-bleeding in adults who have had a severe aneurysmal subarachnoid hemorrhage.
-
Cilostazol to help prevent delayed brain ischemia after aneurysm bleed
This study tests whether cilostazol can reduce delayed brain ischemia and improve outcomes after aneurysmal subarachnoid hemorrhage in adults who had recent aneurysm treatment.
-
Transcutaneous Vagal Nerve Stimulation to help with brain vessel narrowing after aneurysm rupture
This trial tests whether using a noninvasive nerve stimulation device can reduce cerebral vasospasm after an aneurysmal brain bleed in adults 18–65 who are undergoing standard treatment.
-
Tocilizumab-aazg to reduce stroke risk after a ruptured brain aneurysm
This trial will try to see if a single IV dose of tocilizumab-aazg is safe and can help prevent delayed strokes in adults who have had a ruptured brain aneurysm (aneurysmal subarachnoid hemorrhage).
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.