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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Endovascular Thrombectomy | Active Comparator | The patients will be treated with endovascular thrombectomy . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma adsorption | Procedure | Plasma adsorption was initiated after endovascular thrombectomy once daily for 3 days. |
|
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang | Contact | 0086-13756661217 | doctor_yangyi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenni Guo, MD,PhD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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| Endovascular Thrombectomy | Procedure | The patients will be treated with endovascular thrombectomy. |
|
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) |
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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013514 | Surgical Procedures, Operative |