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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.
This is a prospective, randomized, controlled trial evaluating Adacolumn therapy in patients with acute ischemic stroke due to anterior circulation large-artery occlusion presenting within 10 hours of stroke onset. Eligible patients who meet all inclusion and no exclusion criteria will be randomized in a 1:1 ratio to the Adacolumn group or the control group, with 5 patients enrolled in each arm (total n=10).
All participants will have undergone guideline-based endovascular thrombectomy for acute ischemic stroke, together with standard medical management. In the Adacolumn group, each patient will undergo four scheduled Adacolumn treatment sessions in addition to endovascular thrombectomy and standard medical therapy. Patients in the control group will receive endovascular thrombectomy and standard medical treatment alone. Each participant will be followed for 90 days after enrollment.
The objective of the trial is to evaluate the effect of Adacolumn therapy on cerebral edema in patients with anterior circulation large-artery occlusion stroke. The primary endpoint is the change in net water uptake (NWU) measured on CT at 72-78 hours post reperfusion, compared to the immediate post-reperfusion CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Adacolumn® | Experimental | Adacolumn Treatment Combined with Endovascular Thrombectomy and Standard Medical Therapy |
|
| Standard Treatment | Active Comparator | Endovascular Thrombectomy and Standard Medical Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adacolumn® | Device | Adacolumn treatment :once a day for 4 consecutive days after enrollment (60 minutes each time, blood flow rate 30 mL/min, total blood volume processed 1800 mL); the treatment was performed by establishing extracorporeal circulation through bilateral arm veins, and a total of 4 adsorption treatments were completed. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion | The change in net water uptake (NWU) measured on CT at 72-78 hours post-reperfusion, compared to the immediate post-reperfusion CT | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events (SAEs) related to Adacolumn treatment (Primary Safety Outcome) | Adacolumn treatment-related SAEs specifically including but not limited to: hypotension requiring vasopressor support (systolic blood pressure <90 mmHg); access site hemorrhage or hematoma; infection (manifested as fever or access site erythema); electrolyte disturbances such as hypokalemia or hypocalcemia; thrombocytopenia (platelet count <100 × 10⁹/L); and any other event judged by the investigator to be a treatment-related SAE. |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic changes in peripheral blood immune cells before and after Adacolumn therapy | Baseline up to Day 3、 Day 7 | |
| Cerebral immune cell infiltration analysis | For patients undergoing decompressive craniectomy combined with internal decompression, intraoperative brain tissue samples will be collected from the infarct region. These specimens will be subjected to comprehensive analysis to characterize the infiltration, including quantification, phenotypic identification, and functional assessment of immune cells |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Zhang | Contact | +86 13805722695 | zjm135@zju.edu.cn | |
| Ligen Shi | Contact | +86 13732233245 | slg0904@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 311221 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26818659 | Background | Dignass A, Akbar A, Hart A, Subramanian S, Bommelaer G, Baumgart DC, Grimaud JC, Cadiot G, Makins R, Hoque S, Bouguen G, Bonaz B. Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results. J Crohns Colitis. 2016 Jul;10(7):812-20. doi: 10.1093/ecco-jcc/jjw032. Epub 2016 Jan 27. | |
| 28229893 |
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|
| Endovascular Thrombectomy | Procedure | Endovascular thrombectomy will be performed in strict accordance with the indications, contraindications, and operational specifications outlined in the Chinese Stroke Society Guidelines for Reperfusion Therapy in Acute Ischemic Stroke (2024), as well as the latest official instructions for use of the relevant endovascular devices and adjunctive medications. |
|
| Standard medical management | Drug | Standard medical management for ischemic stroke. |
|
| Randomization to Day 90 |
| The number of discontinuation of Adacolumn therapy due to adverse events (Safety Outcome) | Record the number of patients who permanently discontinued Adacolumn therapy during the treatment period specifically due to SAEs | Randomization up to Day 3 |
| The change in midline shift on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion | 72 hours |
| Change in National Institutes of Health Stroke Scale (NIHSS) score on day 7 post-treatment compared to immediate post-operative baseline | Day 7 |
| Number of participants who developed brain herniation after treatment | Baseline up to Day 14 |
| Number of participants who underwent decompressive craniectomy (DC) | Baseline up to Day 14 |
| modified Rankin Scale (mRS) Score | Day 90 |
| Number of participants who achieved mRS 0-2 | Day 90 |
| Number of participants who achieved mRS 0-3 | Day 90 |
| Number of participants with death | Baseline up to Day 90 |
| The relative percentage change in DWI edema volume at day 4 post-reperfusion compared to the immediate post-reperfusion DWI | Day 4 |
| The relative percentage change in DWI infarct volume at day 4 post-reperfusion compared to the immediate post-reperfusion DWI | Day 4 |
| Baseline up to Day 14 |
| Background |
| Elkins J, Veltkamp R, Montaner J, Johnston SC, Singhal AB, Becker K, Lansberg MG, Tang W, Chang I, Muralidharan K, Gheuens S, Mehta L, Elkind MSV. Safety and efficacy of natalizumab in patients with acute ischaemic stroke (ACTION): a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2017 Mar;16(3):217-226. doi: 10.1016/S1474-4422(16)30357-X. Epub 2017 Feb 15. |
| 40543039 | Background | Ren T, Zhu M, Jiang X, Xu L, Jin H, Zhou Y, Zhao Y, Zhuo R, Li W, Chen C, Peng L, Jin X, Li Y, Yang L. Targeting microglial PPARalpha ameliorates the outcome of ischemic stroke by enhancing interaction with infiltrating peripheral monocytes/macrophages. Cell Rep. 2025 Jul 22;44(7):115875. doi: 10.1016/j.celrep.2025.115875. Epub 2025 Jun 20. |
| 31296369 | Background | Shi K, Tian DC, Li ZG, Ducruet AF, Lawton MT, Shi FD. Global brain inflammation in stroke. Lancet Neurol. 2019 Nov;18(11):1058-1066. doi: 10.1016/S1474-4422(19)30078-X. Epub 2019 Jul 8. |
| 19747656 | Background | Huttner HB, Schwab S. Malignant middle cerebral artery infarction: clinical characteristics, treatment strategies, and future perspectives. Lancet Neurol. 2009 Oct;8(10):949-58. doi: 10.1016/S1474-4422(09)70224-8. |
| 30571414 | Background | Wu S, Yuan R, Wang Y, Wei C, Zhang S, Yang X, Wu B, Liu M. Early Prediction of Malignant Brain Edema After Ischemic Stroke. Stroke. 2018 Dec;49(12):2918-2927. doi: 10.1161/STROKEAHA.118.022001. |
| 29789393 | Background | Sheth KN, Petersen NH, Cheung K, Elm JJ, Hinson HE, Molyneaux BJ, Beslow LA, Sze GK, Simard JM, Kimberly WT. Long-Term Outcomes in Patients Aged </=70 Years With Intravenous Glyburide From the Phase II GAMES-RP Study of Large Hemispheric Infarction: An Exploratory Analysis. Stroke. 2018 Jun;49(6):1457-1463. doi: 10.1161/STROKEAHA.117.020365. Epub 2018 May 22. |
| 30798266 | Background | Huang X, Yang Q, Shi X, Xu X, Ge L, Ding X, Zhou Z. Predictors of malignant brain edema after mechanical thrombectomy for acute ischemic stroke. J Neurointerv Surg. 2019 Oct;11(10):994-998. doi: 10.1136/neurintsurg-2018-014650. Epub 2019 Feb 23. |
| ID | Term |
|---|---|
| D001929 | Brain Edema |
| D000083242 | Ischemic Stroke |
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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