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

Summary

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

• Aneurysmal Subarachnoid Hemorrhage

Interventions

DRUG

Urokinase

On 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.

DRUG

Placebo

On 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• Ganzhou City People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Xianning Central Hospital

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• Panzhihua Central Hospital

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• The Second Military Medical University Changhai Hospital

  collaborator UNKNOWN

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• 904th Hospital of the Joint Logistics Support Force of the PLA

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Dezhou Hospital Qilu Hospital of Shandong University

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Jiujiang No.1 People's Hospital

  collaborator OTHER

• The First People's Hospital of Changde City

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  lead OTHER

Principal Investigators

• Xingen Zhu, MS · Second Affiliated Hospital of Nanchang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-28

Primary Completion

2027-06-30

Completion

2027-12-30

Countries

• China

Study Locations