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

NCT07042490 | Not Yet Recruiting DMC

• 1 other identifier: PROMOTE-EVT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion; Endovascular Thrombectomy

Keywords

Acute ischemic stroke; Plasma adsorption; Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 at 90 days

  90±7 days

• Ordinal distribution of Modified Rankin Scale (mRS)

  90±7 days

• Proportion of patients with a reduction of NIHSS score（≥4 points）

  7 days(or discharge)

• Blood lipid in peripheral blood

  72 hours, 7 days

• Cytokine levels in peripheral blood

  72 hours, 7 days

Other Outcomes (5)

• All-cause mortality

  90±7 days，at the discharge, whichever came first

• Frequency of new intracerebral hemorrhage within 7 days

  7 days

• Frequency of adverse events within 90 days

  90±7 days

Study Arms (2)

Plasma adsorption+Endovascular Thrombectomy

EXPERIMENTAL

Patients are received plasma adsorption and endovascular thrombectomy.Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days.

Procedure: Plasma adsorption; Procedure: Endovascular Thrombectomy

Endovascular Thrombectomy

ACTIVE COMPARATOR

The patients will be treated with endovascular thrombectomy .

Procedure: Endovascular Thrombectomy

Interventions

Plasma adsorption PROCEDURE

Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days.

Plasma adsorption+Endovascular Thrombectomy

Endovascular Thrombectomy PROCEDURE

The patients will be treated with endovascular thrombectomy.

Endovascular Thrombectomy; Plasma adsorption+Endovascular Thrombectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)）.
• Pregnancy , lactation or life expectancy of less than 3 months or inability to complete the study for other reasons.
• Unwilling to be followed up or poor compliance.
• Current or past participation in other clinical research, or participation in this study within 3 months prior to admission.
• Other conditions that the researchers think make the patient unsuitable for the study.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Zhenni Guo, MD,PhD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Yang

CONTACT

0086-13756661217; doctor_yangyi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 29, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 29, 2025

Record last verified: 2024-11

Locations

CN (1)