ArticleTrials2026
Early lumbar drainage plus intrathecal urokinase in severe aneurysmal subarachnoid hemorrhage: the LD-ITUK randomized controlled trial protocol.
Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06284642 (Effectiveness and Safety of Early Lumbar Drainage Plus Intrathecal Urokinase Injection in the Treatment of Severe Aneurysmal Subarachnoid Hemorrhage), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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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
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16 authors.
Funding
Abstract
backgroundDespite advances in embolization techniques and neurocritical care, patients with severe aneurysmal subarachnoid hemorrhage (SaSAH) continue to face substantial risk of morbidity and long-term disability. The presence of subarachnoid blood and its breakdown products significantly contributes to secondary brain injury and subsequent complications. Although the EARLYDRAIN trial demonstrated a benefit from lumbar drainage in clearing blood, this method alone is insufficient to remove clots located above the fourth ventricle. Urokinase, a fibrinolytic agent, offers a potential means to enhance clot clearance. However, the combined strategy of lumbar drainage plus intrathecal urokinase (LD-ITUK) has not yet been rigorously evaluated. METHODS/
designThis is an investigator-initiated, multicenter, prospective, randomized, double-blind, placebo-controlled superiority trial. It aims to compare the efficacy of LD-ITUK against lumbar drainage alone (with intrathecal saline) in patients with SaSAH, when added to standard care. A total of 424 eligible patients will be randomized in a 1:1 ratio to receive either the intervention (LD-ITUK) or the control treatment (lumbar drainage plus intrathecal saline). Eligible participants are adults with a first-episode aSAH, clinically graded as Hunt-Hess III to V, whose ruptured aneurysm has been secured via surgical clipping or endovascular coiling within 48 h after onset. The primary outcome is the proportion of patients achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0 to 2 at 180 days after onset, as adjudicated by an independent Outcome Adjudication Committee (OAC) blinded to treatment allocation. DISCUSSION: This trial will determine whether the LD-ITUK method could improve the long-term functional outcomes compared to the current standard treatment in patients with SaSAH.
trial registrationClinicalTrials.gov NCT06284642. Registered 28 February 2024.
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