Efficacy and Safety of Plasma Adsorption Combined With EVT for AIS-LVO

Launched by YI YANG · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have had a severe type of stroke caused by a blockage in a large blood vessel in the brain. After patients undergo a procedure called endovascular thrombectomy (EVT), which removes the blockage, this study will test whether adding a treatment called plasma adsorption can help improve recovery and is safe to use. Plasma adsorption is a process that cleans the blood by removing harmful substances that might affect healing after a stroke.

The trial is looking for adults between 18 and 80 years old who have recently had this type of stroke and have successfully had the blockage cleared with EVT. Participants need to have certain levels of stroke severity and be able to start the plasma adsorption treatment within 12 hours after their procedure. If someone joins, they will receive this additional blood-cleaning treatment and be closely monitored to see how well it works and if there are any side effects. The study excludes people with serious complications after stroke, certain health problems, or who are pregnant. This research is not yet recruiting patients but aims to find better ways to support stroke recovery in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-80 years, male or female.
• • 2. 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).
• • 3. Baseline NIHSS after EVT ≥ 6 and ≤25 points.
• • 4. Randomization and the first plasma adsorption can be initiated within 12 hours after EVT.
• • 5. Pre-stroke mRS≤ 2 points.
• • 6. Patient/legally family members have signed the Informed consent form.
• Exclusion Criteria:
• • 1. Imaging after EVT indicated malignant brain edema with midline shift or brain herniation and surgical treatment was planned.
• • 2. Parenchymal hemorrhage type 1, or type 2 confirmed by CT.
• • 3. Allergic to any ingredient of the plasma separator, the adsorption device, or the piping.
• • 4. 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.
• • 5. Previous history of malignant tumors, autoimmune diseases or being treated with immunosuppressants, hormones, or tumor necrosis factor inhibitors.
• • 6. Previous history of organic heart disease and NYHA Class III or IV.
• • 7. 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).
• • 8. 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)）.
• • 9. Pregnancy , lactation or life expectancy of less than 3 months or inability to complete the study for other reasons.
• • 10. Unwilling to be followed up or poor compliance.
• • 11. Current or past participation in other clinical research, or participation in this study within 3 months prior to admission.
• • 12. Other conditions that the researchers think make the patient unsuitable for the study.