protocolSection identificationModule nctId: NCT06284642, orgStudyIdInfo id: LD-ITUK-2024-001, briefTitle: Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Nanchang University, class: OTHER, collaborators name: Changhai Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Aneurysmal Subarachnoid Hemorrhage, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 424, type: ESTIMATED, armsInterventionsModule interventions name: Urokinase, interventions name: Placebo, outcomesModule primaryOutcomes measure: Modified Rankin Scale (mRS), secondaryOutcomes measure: Modified Rankin Scale (mRS), secondaryOutcomes measure: Relative Modified Rankin Scale (mRS), secondaryOutcomes measure: Modified Rankin Scale (mRS) distribution, secondaryOutcomes measure: Glasgow Outcome Scale (GOS）, secondaryOutcomes measure: Questionnaire EuroQol Five Dimensions Questionnaire (EQ-5D), secondaryOutcomes measure: Barthel Index for Activities of Daily Living (BI), secondaryOutcomes measure: Total hospitalized time, secondaryOutcomes measure: Total hospitalized costs, secondaryOutcomes measure: Cerebral vasospasm (CV), secondaryOutcomes measure: Delayed cerebral ischemia (DCI), secondaryOutcomes measure: Death, secondaryOutcomes measure: Hydrocephalus, secondaryOutcomes measure: Rebleeding, otherOutcomes measure: Subarachnoid hemorrhage volume clearance, otherOutcomes measure: Correlationship between cerebralspinal fluid pressure with subarachnoid hemorrhage volume, otherOutcomes measure: Correlationship between clinical grades and subarachnoid hemorrhage volume, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Nanchang University, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Xingen Zhu, MS, role: CONTACT, email: zxg2008vip@163.com, geoPoint lat: 28.68396, lon: 115.85306, hasResults: False