Combining lumbar drainage with urokinase for treating severe aneurysmal subarachnoid hemorrhage

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

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
• Enrollment: 424 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 25 sites (Hefei, Anhui and 24 other locations)
• Trial ID: NCT06284642 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility 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 this trial is running

Hefei, Anhui and 24 other locations

• 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)
• 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

Conditions Aneurysmal Subarachnoid Hemorrhage