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

Efficacy and Safety of Plasma Adsorption Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke From Large Vessel Occlusion; Endovascular Thrombectomy
• Intervention / Treatment: Procedure: Plasma adsorption; Procedure: Endovascular Thrombectomy

Detailed Description

Large vessel occlusive (LVO) stroke has a higher mortality and disability rate than other types of acute ischemic stroke (AIS). Endovascular thrombectomy (EVT) is recommended as a standard treatment for AIS-LVO. However, even if the blood vessels are successfully recanalization, nearly one-third of the patients still die and nearly half remain disabled at 3 months. Inflammation plays a crucial role in the pathophysiological cascade of ischemic stroke and related forms of brain injury. Evidence from experimental stroke indicates that targeting cytokines may reduce infarct volume and promote functional recovery. Plasma adsorption (PA) has been applied in the treatment of severe inflammatory diseases, including pancreatitis and sepsis, as well as in the neurological autoimmune diseases, such as myasthenia gravis, multiple sclerosis, and autoimmune encephalitis. We hypothesize that PA can improve functional outcome of AIS-LVO who underwent EVT.

In this study, the experimental group receive EVT and PA, 1 time per day for 3 consecutive days. The control group receive EVT . Two groups will be followed up for 90 days to evaluate the efficacy and safety of PA for patients of AIS-LVO of anterior circulation, who achieve successful recanalization through EVT.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Hospital of Jilin University
      • Contact: Yi Yang, MD,PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plasma adsorption+Endovascular Thrombectomy; Patients are received plasma adsorption and endovascular thrombectomy.Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days.	Procedure: Plasma adsorption; Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days.; Procedure: Endovascular Thrombectomy; The patients will be treated with endovascular thrombectomy.
Active Comparator: Endovascular Thrombectomy; The patients will be treated with endovascular thrombectomy .	Procedure: Endovascular Thrombectomy; The patients will be treated with endovascular thrombectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days	Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 at 90 days	Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents an excellent outcome.	90±7 days
Ordinal distribution of Modified Rankin Scale (mRS)	Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).	90±7 days
Proportion of patients with a reduction of NIHSS score（≥4 points）	The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.	7 days(or discharge)
Blood lipid in peripheral blood	Blood lipid in peripheral blood，including total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides. are assessed at 72 hours and 7 days from randomization.	72 hours, 7 days
Cytokine levels in peripheral blood	Cytokines such as pro-inflammatory factors including interleukins are assessed at 72 hours and 7 days from randomization.	72 hours, 7 days
Final infarct volume	Final infarct volume measured with diffusion weighted imaging (DWI) MRI.	7 days (or discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality is defined as death from any cause occurring during the study period.	90±7 days，at the discharge, whichever came first
Frequency of new intracerebral hemorrhage within 7 days	Evaluate new intracerebral hemorrhage， including symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage.	7 days
Frequency of adverse events within 90 days	Frequency of adverse events within 90 days.	90±7 days
Frequency of serious adverse events within 90 days	Frequency of serious adverse events within 90 days.	90±7 days
Frequency of adverse events associated with plasma adsorption within 90 days	Frequency of adverse events associated with plasma adsorption within 90 days.	90±7 days

Collaborators and Investigators

• Sponsor: Yi Yang
• Investigators: Principal Investigator: Zhenni Guo, MD,PhD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 17, 2025
• First Submitted That Met QC Criteria: June 27, 2025
• First Posted (Actual): June 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; Endovascular Thrombectomy; Plasma adsorption
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Ischemic Stroke; Stroke; Ischemia
• Other Study ID Numbers: PROMOTE-EVT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No