[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615575":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":34,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":18,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":18,"enrollmentInfo":51,"targetDuration":18,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":18,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":18},{"fullName":5,"class":6},"Tianjin Huanhu Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Albumin Group","EXPERIMENTAL","Subjects assigned to the albumin treatment group after achieving successful recanalization (eTICI ≥ 2b) confirmed by DSA post-thrombectomy will receive a 20% human albumin solution at a dose of 0.60 g\u002Fkg. The solution will be administered as a constant-rate infusion into the proximal internal carotid artery over 20 minutes. Vital signs and potential infusion-related reactions must be closely monitored throughout the procedure.",[13],"Drug: Human serum albumin infusion 20%",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Subjects in the control group who have achieved successful recanalization (eTICI ≥ 2b) as confirmed by DSA following mechanical thrombectomy will not receive the investigational infusion and will undergo standard medical management only.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Human serum albumin infusion 20%","20% human albumin solution at a dose of 0.60 g\u002Fkg will be administered as a constant-rate infusion into the proximal internal carotid artery over 20 minutes.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Ming Wei PhD, PhD","CONTACT","86+13502182903","weiming@tmu.edu.cn",{"name":32,"role":28,"phone":18,"phoneExt":18,"email":33},"Du, PhD","dkj1024@163.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ming Wei","PhD",[39],{"name":40,"class":41},"The First Hospital of Qinhuangdao","OTHER_GOV","100615575","phase-2-the-preliminary-efficacy-and-safety-of-intra-arterial-albumin-as-adjunct-to-mechanical-thrombectomy-in-acute-ischemic-stroke-100615575",false,"NCT07294391","The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke","The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke：Dual-Center, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* 1.Age ≥ 18 years; 2.ICA or MCA-M1 occlusion, confirmed by preoperative CTA\u002FMRA\u002FDSA. ICA occlusion can be cervical or intracranial, with or without tandem MCA lesions; Treated with EVT resulting in recanalization ((expanded Thrombolysis in Cerebral Infarction \\[eTICI\\] 2b-3); 3.Baseline NIHSS scores ≥ 6; 4.Baseline ASPECTS ≥6 on non-contrast CT; 5.The time from stroke onset\u002Flast seen well to arterial puncture is within 24 hours; 6.No significant pre-stroke disability (pre-stroke mRS ≤2); 7.Signed informed consent from the patient or the legally authorized representative\n\nExclusion Criteria:\n\n* 1.Presence of intracranial hemorrhage on head CT or MRI； 2.Midline shift with significant mass effect on head CT or MRI； 3.History of heart failure or severe cardiovascular disease, including but not limited to pulmonary hypertension, pericardial effusion, etc； 4.Arrhythmia accompanied by hemodynamic instability； 5.Symptoms or electrocardiographic evidence of acute myocardial infarction upon admission； 6.Acute or chronic renal failure (serum creatinine \\>2.0 mg\u002FdL)； 7.Severe anemia (hematocrit \\\u003C32%)； 8.Known allergy to albumin or blood products； 9.Pregnant women； 10.Persistent blood pressure ≥180\u002F100 mmHg prior to albumin infusion； 11.Concurrent participation in another clinical trial； 12.Life expectancy of less than 3 months； 13.Coexisting severe pulmonary diseases such as Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, pleural effusion, pulmonary hypertension, or acute respiratory distress syndrome； 14.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.","ALL","18 Years",{"count":52,"type":53},60,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","Albumin-assisted therapy has demonstrated good safety and potential neuroprotective effects following mechanical thrombectomy. To further systematically evaluate its efficacy and safety, we are conducting a Phase IIa clinical trial of intra-arterial albumin administration combined with mechanical thrombectomy in patients with acute ischemic stroke. This is a double-center, prospective, open-label, endpoint-blinded, randomized controlled trial designed to preliminarily assess the efficacy and safety of intra-arterial infusion of 20% human albumin after successful recanalization in patients with acute ischemic stroke caused by anterior circulation large-vessel occlusion who undergo mechanical thrombectomy. A total of 60 patients will be enrolled and randomized in a 1:1 ratio by dynamic minimization into two groups: the albumin group (0.6 g\u002Fkg of 20% human albumin solution plus mechanical thrombectomy) and the control group (mechanical thrombectomy alone).\n\nThe primary objective of this study is to preliminarily evaluate whether intra-arterial infusion of 0.6 g\u002Fkg of 20% human albumin via the internal carotid artery immediately after achieving successful recanalization (eTICI ≥ 2b) can reduce infarct volume compared with mechanical thrombectomy alone in patients with anterior circulation large-vessel occlusion who undergo standard mechanical thrombectomy. The secondary objective is to assess the safety and feasibility of intra-arterial infusion of 0.6 g\u002Fkg of 20% human albumin immediately after successful recanalization in this patient population.",[59],"Acute Ischemic Stroke From Large Vessel Occlusion",[61,62,63,64,65],"Acute ischemic stroke","large vessel occlusion","mechanical thrombectomy","albumin","neuroprotection","NOT_YET_RECRUITING","2025-12-07",{"date":69,"type":70},"2025-12-19","ACTUAL",{"date":72,"type":53},"2025-12-10",{"date":74,"type":53},"2026-12-01",{"name":5,"class":6}]