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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
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.
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 for ischemic stroke.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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
Time frame: 72 hours
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.
Time frame: 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
Time frame: Randomization up to Day 3
The change in midline shift on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion
Time frame: 72 hours
Change in National Institutes of Health Stroke Scale (NIHSS) score on day 7 post-treatment compared to immediate post-operative baseline
Time frame: Day 7
Number of participants who developed brain herniation after treatment
Time frame: Baseline up to Day 14
Number of participants who underwent decompressive craniectomy (DC)
Time frame: Baseline up to Day 14
modified Rankin Scale (mRS) Score
Time frame: Day 90
Number of participants who achieved mRS 0-2
Time frame: Day 90
Number of participants who achieved mRS 0-3
Time frame: Day 90
Number of participants with death
Time frame: 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
Time frame: Day 4
The relative percentage change in DWI infarct volume at day 4 post-reperfusion compared to the immediate post-reperfusion DWI
Time frame: Day 4
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