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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Aneurysmal Subarachnoid Hemorrhage

In brief

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.

Key facts

Study ID

NCT06284642

Run by

Second Affiliated Hospital of Nanchang University

People needed

424

Starts

2024-03-28

Expected to finish

2027-12-30

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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