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.
Patient's age ≥ 18 years
First occurrence of aneurysmal subarachnoid hemorrhage
Patients without any craniotomy treatment before onset
Hunt-Hess grade III-V
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
Parallel
Urokinase
DrugOn the basis of standard treatment for severe neurological conditions, within 24 hours of aneurysm treatment, lumbar drainage combined with intrathecal urokinase injection was started. 30,000 IU urokinase dissolved in 3 ml normal saline was injected into the subarachnoid space, 3 ml normal saline was rinsed into the tube, and the tube was clamped for observation for 2 hours, once a day, for 3 consecutive days. Lumbar cisternae drainage Cerebrospinal fluid is slowly and steadily drained at a rate of less than 8ml/h per hour, the daily drainage volume is not more than 200 ml, and the drainage time of lumbar cisternae is controlled within 7 to 10 days, not more than 14 days.
Placebo
DrugOn the basis of standard treatment for severe neurological conditions, the treatment of lumbar drainage combined with intrathecal placebo saline injection was started within 24 hours after aneurysm treatment, 3 ml placebo was injected into the subarachnoid space, 3 ml normal saline was flushed into the tube, and the tube was observed for 2 hours, once a day for 3 consecutive days. Lumbar cisternae drainage Cerebrospinal fluid is slowly and steadily drained at a rate of less than 8ml/h per hour, the daily drainage volume is not more than 200 ml, and the drainage time of lumbar cisternae is controlled within 7 to 10 days, not more than 14 days.
Modified Rankin Scale (mRS)
Good (mRS 0-2) and Poor (mRS 3-6)
Modified Rankin Scale (mRS)
Good (mRS 0-2) and Poor (mRS 3-6)
Relative Modified Rankin Scale (mRS)
Good (mRS 0-3) and Poor (mRS 4-6)
Modified Rankin Scale (mRS) distribution
On the distributed proportion in scores (0-6) on the mRS
Glasgow Outcome Scale (GOS）
Good (GOS 4-5) and Poor (GOS 1-3)
Subarachnoid hemorrhage volume clearance
dynamic clearance of subarachnoid hemorrhage volume on non-contrast CT scans ofter-onset to discharge
Correlationship between cerebralspinal fluid pressure with subarachnoid hemorrhage volume
correlationship between admission cerebralspinal fluid pressure with subarachnoid hemorrhage volume
Correlationship between clinical grades and subarachnoid hemorrhage volume
correlationship between Hunt-Hess grade, WFNS, modified Fisher scale with subarachnoid hemorrhage volume
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Second Affiliated Hospital of Nanchang University
Lead sponsor
First Affiliated Hospital of Fujian Medical University
Collaborator
Huashan Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
Tongji Hospital
Collaborator
Southern Medical University, China
Collaborator
Qilu Hospital of Shandong University
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Zhongnan Hospital
Collaborator
Zhejiang University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Xiangya Hospital of Central South University
Collaborator
First Affiliated Hospital of Gannan Medical University
Collaborator
Ganzhou City People's Hospital
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Renmin Hospital of Wuhan University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Yichang Central People's Hospital
Collaborator
Xianning Central Hospital
Collaborator
Linyi People's Hospital
Collaborator
Panzhihua Central Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The Second Military Medical University Changhai Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
904th Hospital of the Joint Logistics Support Force of the PLA
Collaborator
Qianfoshan Hospital
Collaborator
Dezhou Hospital Qilu Hospital of Shandong University
Collaborator
Liaocheng People's Hospital
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Jiujiang No.1 People's Hospital
Collaborator
The First People's Hospital of Changde City
Collaborator
