Actively Recruiting
Early Lumbar Drainage Plus Intrathecal Urokinase in Severe Aneurysmal Subarachnoid Hemorrhage (LD-ITUK)
Led by Second Affiliated Hospital of Nanchang University · Updated on 2026-05-05
424
Participants Needed
25
Research Sites
196 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Nanchang University
Lead Sponsor
F
First Affiliated Hospital of Fujian Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Lumbar Drainage Plus Intrathecal Urokinase in Severe Aneurysmal Subarachnoid Hemorrhage (LD-ITUK)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient's age 63 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
You will not qualify if you...
- 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 known to be allergic to urokinase and excipients or with a history of severe allergy and deemed unsuitable by investigators
- Participated in another interventional clinical trial within 30 days before randomization
- Other reasons deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 25 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Heihe, Anhui, China, 230000
Actively Recruiting
3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350000
Actively Recruiting
4
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
5
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Actively Recruiting
6
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
7
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
8
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Actively Recruiting
9
Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
10
Union hospital,Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
11
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Actively Recruiting
12
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
13
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
14
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, China, 210000
Actively Recruiting
15
904th Hospital of Joint Logistic Support Force of PLA
Wuxi, Jiangsu, China, 214000
Actively Recruiting
16
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
17
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
18
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
19
Qilu hospital of shandong university
Jinan, Shandong, China, 250000
Actively Recruiting
20
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250000
Actively Recruiting
21
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
22
Huashan hospital of fudan university
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
23
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
24
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
25
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xingen Zhu, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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