[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-cerebral-edema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-cerebral-edema":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100622641","a-trial-of-adacolumn-on-cerebral-edema-after-anterior-circulation-ischemic-stroke-100622641",false,"NCT07386262","A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke","Efficacy and Safety of the Adacolumn® Granulocyte and Monocyte\u002FMacrophage Apheresis Device for Cerebral Edema After Acute Anterior Circulation Occlusive Cerebral Infarction: A Prospective, Randomized, Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 18-80 years, regardless of gender;\n2. A clinical diagnosis of acute ischemic stroke;\n3. Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA or DSA;\n4. NIHSS score ≥10 at screening;\n5. Pre-stroke mRS score \\\u003C2 (independent in all activities of daily living);\n6. Time from stroke onset to initiation of the first Adacolumn treatment is ≤24 hours, stroke onset is defined as the last time the patient was known to be at their neurological baseline (wake-up strokes qualify if within this time window);\n7. All endovascular thrombectomy procedures must strictly adhere to the \"2024 Chinese Stroke Association Guidelines for Reperfusion Therapy in Acute Ischemic Stroke\" and the latest prescribing information\u002Finstructions for use regarding indications, contraindications, and procedural standards;\n8. Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;\n2. Patients who receive intravenous thrombolysis (including bridging therapy) for the index ischemic stroke episode before or during endovascular thrombectomy; or undergo permanent intracranial or extracranial stent implantation (including intracranial stent-assisted thrombectomy or carotid stenting) during the index endovascular procedure;\n3. After endovascular thrombectomy: extensive contrast extravasation (diffuse subarachnoid high density or parenchymal high density not consistent with hematoma), new subarachnoid hemorrhage（SAH）, or symptomatic intracranial hemorrhage (sICH);\n4. Large-vessel occlusion is attributed to other determined etiologies per TOAST classification, such as tumor-related, dissection-related, or other clearly identifiable non-LAA\u002Fnon-CE causes.\n5. Clinical signs of brain herniation, such as unilateral or bilateral fixed dilated pupils and\u002For other loss of brainstem reflexes attributable to cerebral edema or herniation in the investigator's opinion;\n6. Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm);\n7. Inability to undergo MRI;\n8. Absolute neutrophil count \\\u003C1.5×10⁹\u002FL or \\>15×10⁹\u002FL\n9. Absolute monocyte count \\> 1.0 ×10⁹\u002FL;\n10. Red blood cells \\\u003C3.0×10¹²\u002FL ;\n11. Active internal bleeding or bleeding tendency (such as platelet count \\\u003C100×10⁹\u002FL, INR \\>1.7, PT \\>15 seconds);\n12. Marked hypercoagulability (fibrinogen \\>700 mg\u002FdL);\n13. Intracranial or spinal surgery or severe head trauma within the past 3 months;\n14. Refractory hypertension (persistent systolic blood pressure \\>185 mmHg or diastolic \\>110 mmHg);\n15. Known allergy to components of the blood purification system (including adsorption membrane, anticoagulants);\n16. Acute ST-segment elevation myocardial infarction and\u002For acute decompensated heart failure and\u002For corrected QT interval \\>520 ms and\u002For history of cardiac arrest within the past 6 months(pulseless electrical activity, ventricular tachycardia, ventricular fibrillation, or asystole);\n17. Body temperature \\>38°C or active infection;\n18. Active autoimmune disease or immunodeficiency;\n19. Participation in another interventional clinical trial within the past 30 days;\n20. Any other condition deemed unsuitable for participation by the investigator.","ALL","18 Years","80 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.",[27,28,29,30],"Cerebral Edema","Ischemic Stroke, Acute","Malignant Cerebral Edema","Anterior Circulation Brain Infarction","NOT_YET_RECRUITING","2026-05-03",{"date":34,"type":35},"2026-05-05","ACTUAL",{"date":37,"type":21},"2026-05-01",{"date":39,"type":21},"2028-12-31",{"name":41,"class":42},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100607994","expansion-floating-craniotomy-for-the-treatment-of-malignant-cerebral-edema-caused-by-acute-ischemic-stroke-100607994","NCT07195786","Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke","Expansion-floating Craniotomy for the Treatment of Malignant Cerebral Edema Caused by Acute Ischemic Stroke--A Prospective, Multicenter, Non-inferiority,Cohort Study（ECAIS）","ECAIS","Inclusion Criteria:\n\n* Age requirement: Adults aged \\>18 but \\\u003C80 years\n* Acute cerebral infarction diagnosis: Patients with internal carotid artery or middle cerebral artery occlusion within 48 hours, meeting all three criteria:\n\nNIHSS score ≥16 with item 1a (level of consciousness) ≥1 CT demonstrating \\>50% MCA territory infarction or hypoperfused area \\>2\u002F3, OR DWI hyperintensity volume \\>82 ml within 6 hours of onset, OR DWI infarct volume \\>145 ml within 14 hours\n\n* Imaging evidence: Midline shift ≥5 mm to the contralateral side on CT, OR significant ipsilateral ventricular compression with effacement of cerebral sulci\u002Fcisterns.\n\nExclusion Criteria:\n\n* Pre-stroke mRS score ≥1\n* Significant contralateral cerebral infarction\n* Symptomatic intracranial hemorrhage\n* Any known coagulopathy\n* Life expectancy \\\u003C3 years\n* Any severe comorbidities potentially interfering with treatment evaluation",{"count":53,"type":21},356,"3 Months","OBSERVATIONAL","This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke). Malignant edema causes rapid increases in intracranial pressure, compressing vital brain structures and risking fatal brain herniation, requiring urgent intervention.\n\nThe current international standard treatment is traditional decompressive craniectomy (DC). DC involves removing a section of the skull to allow brain swelling, effectively reducing pressure and mortality risk. It is strongly recommended (Class I, Level A evidence) in major guidelines. However, DC typically requires a second major surgery (cranioplasty) approximately 3 months later to replace the removed bone flap, involving additional costs and risks like progressive intracranial hemorrhage or subdural hygroma.\n\nEC is a newer approach designed to potentially eliminate the need for a second surgery. During EC, surgeons use medical titanium plates to temporarily elevate the bone flap, creating immediate space for brain swelling while keeping the bone flap attached. Once brain swelling subsides (usually within weeks), a minor procedure flattens the titanium plates, allowing the patient's own bone to naturally reposition without requiring cranioplasty. EC may be performed based on surgeon assessment of brain swelling, guideline considerations, or experience. If EC is deemed unsuitable during surgery, DC will be performed instead.\n\nWhile early research suggests EC achieves decompression similar to DC while preserving the bone flap, its safety and effectiveness compared to the established DC procedure are not yet fully proven. DC is a well-understood, mature technique with known risks and benefits, including the certainty of needing cranioplasty. Conservative management is reserved for patients unfit for surgery but may not prevent neurological deterioration.This study aims to conduct a preliminary assessment of the outcomes of EC versus DC.",[28,29],[59,29,60,61],"Expansion-floating Craniotomy","decompressive craniectomy","Acute Ischemic Stroke","2025-09-24",{"date":64,"type":35},"2025-09-29",{"date":66,"type":21},"2025-10-01",{"date":68,"type":21},"2027-05-30",{"name":70,"class":42},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"]