Efficacy and Safety of Plasma Adsorption Combined With EVT for AIS-LVO (NCT07042490) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Plasma Adsorption Combined With EVT for AIS-LVO
China100 participantsStarted 2025-06-30
Plain-language summary
The purpose of this study is to determine the efficacy and safety of plasma adsorption for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80 years, male or female.
✓. Diagnosis of acute ischemic stroke within 12 hours of symptom onset, underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by DSA as ICA,MCA-M1,MCA-M2,ACA-A1,ACA-A2 occlusion or tandem lesion) and achieve successful recanalization (mTICI grade 2b/3).
✓. Baseline NIHSS after EVT ≥ 6 and ≤25 points.
✓. Randomization and the first plasma adsorption can be initiated within 12 hours after EVT.
✓. Pre-stroke mRS≤ 2 points.
✓. Patient/legally family members have signed the Informed consent form.
Exclusion criteria
✕. Imaging after EVT indicated malignant brain edema with midline shift or brain herniation and surgical treatment was planned.
✕. Parenchymal hemorrhage type 1, or type 2 confirmed by CT.
✕. Allergic to any ingredient of the plasma separator, the adsorption device, or the piping.
✕. Contraindications to plasma adsorption, platelet count \<60×10\^9/L,white blood cell\<4×10\^9/L, uncontrolled hypertension with persistent systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg, uncontrolled hypotension, systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg.
✕. Previous history of malignant tumors, autoimmune diseases or being treated with immunosuppressants, hormones, or tumor necrosis factor inhibitors.
What they're measuring
1
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
✕. Previous history of organic heart disease and NYHA Class III or IV.
✕. Currently taking anticoagulant(dabigatran, rivaroxiban, warfarin, etc.), previous history of serious hematological system disorders, or abnormal coagulation function (international normalized ratio \[INR\], activated partial thromboplastin time \[APTT\], prothrombin time \[PT\] upper limit of the normal range).
✕. Severe liver and kidney dysfunction or abnormal laboratory test results（serum aspartate aminotransferase or alanine aminotransferase \>3 times the upper limit of normal, serum creatinine\>265umol/l(\>3mg/dl)）.