Effectiveness and Safety of Early Lumbar Drainage Plus Intrathecal Urokinase Injection in Treating Severe Aneurysmal Subarachnoid Hemorrhage: A Multicenter Randomized Controlled Trial

What this Trial Is About

This trial investigates severe aneurysmal subarachnoid hemorrhage (aSAH), a serious type of stroke with high death and disability rates, particularly in China. Researchers aim to evaluate whether adding lumbar drainage combined with intrathecal urokinase injection to standard treatment improves functional outcomes at six months compared to lumbar drainage with placebo. The study is a multicenter, prospective, randomized, double-blind, placebo-controlled trial designed to assess this approach in patients with severe aSAH. Participants will be randomly assigned to one of two groups. One group receives standard treatment plus lumbar drainage combined with intrathecal urokinase injections of 30,000 IU once daily for three days, started within 24 hours after aneurysm treatment. The other group receives standard treatment with lumbar drainage combined with intrathecal placebo saline injection on the same schedule. Lumbar cerebrospinal fluid drainage is controlled to a slow rate under 8 ml/h, with a maximum daily volume of 200 ml, continued for 7 to 10 days, not exceeding 14 days. During the study, participants will be monitored for their functional status using the modified Rankin Scale at six months, which is the primary outcome. Secondary measures include neurological outcomes at 90 and 180 days, quality of life questionnaires, hospitalization time and costs, and complications such as cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, rebleeding, and mortality. Safety and efficacy assessments will be conducted throughout, with the study ending in late 2027.

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