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

ConditionsAcute Ischemic Stroke From Large Vessel OcclusionEndovascular Thrombectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYi Yang

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Plasma adsorption

    Procedure/Surgery

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

  • Endovascular Thrombectomy

    Procedure/Surgery

    The patients will be treated with endovascular thrombectomy.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Plasma adsorption+Endovascular ThrombectomyExperimental treatment 2 interventions
Group B: Endovascular ThrombectomyActive comparator 1 intervention

Trial outcomes

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.

Time frame
90±7 days

Secondary outcomes

1

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.

Time frame
90±7 days
2

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).

Time frame
90±7 days
3

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.

Time frame
7 days(or discharge)
4

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.

Time frame
72 hours, 7 days

Other outcomes

1

All-cause mortality

All-cause mortality is defined as death from any cause occurring during the study period.

Time frame
90±7 days，at the discharge, whichever came first
2

Frequency of new intracerebral hemorrhage within 7 days

Evaluate new intracerebral hemorrhage， including symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage.

Time frame
7 days
3

Frequency of adverse events within 90 days

Frequency of adverse events within 90 days.

Time frame
90±7 days
4

Frequency of serious adverse events within 90 days

Frequency of serious adverse events within 90 days.

Time frame
90±7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

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