Efficacy and Safety of Young Health Plasma on Acute Stroke

Study Overview
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Brief Summary
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Stroke is one of the main severe disease of public health importance. Recent studies showed that old age is one of the most important factors in influencing the outcome of patients with acute stroke, and the young plasma can reverse age-related brain impairments in mice. Therefore, this pilot study aims to investigate whether young plasma is effective in alleviating brain injury and neurologic deficits induced by acute stroke in patients.

Detailed Description
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This study will enroll 78 stroke patients who have been diagnosed with stroke and meet the inclusion criteria. After successfully meeting initial screening criteria, investigators will contact the family, explain the study, and send a consent form for their review. After that, patients will be given 2 unit/day young health plasma (young plasma exchange) over a course of 3 consecutive days, then investigators will make a neurofunctional assessment before and 7 days, 30 days and 90 days after young health plasma treatment. And Magnetic Resonance of the brain before, 7 days, 14 days and 90 days after young health plasma treatment.

Official Title
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Efficacy and Safety of Young Health Plasma on Acute Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: young Fresh Frozen Plasma
* Drug: old Fresh Frozen Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65-80 years Clinical presentation of spontaneous intracerebral hemorrhage/ischemic stroke CT/MRI/MRA scan compatible with spontaneous intracerebral hemorrhage/ ischemic stroke Time to young plasma treatment < 72 h from symptom onset Glasgow Coma Score > 6 on initial presentation or improvement to a Glasgow Coma Score > 6 within the time frame for enrollment The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml Signed and dated informed consent is obtained TOAST: Large-artery atherosclerosis Exclusion Criteria: Patients who will undergo surgical evacuation of intracerebral hemorrhage/ischemic stroke Inability to undergo neuroimaging with Magnetic Resonance Glasgow Coma Score < 6 Significant past history of disability, modified Rankin Scale（mRS）≥1 Primary intraventricular hemorrhage ICH due to coagulopathy (PT > 15 s or International Normalized Ratio > 1.3, Partial Thromboplastin Time > 36) or trauma Thrombocytopenia: platelet count <100 000 Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described) Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome Known pregnancy, or positive pregnancy test, or breast feeding Malignancy (history of or active) Bradyarrhythmia and Atrioventricular Block Concomitant use with antineoplastic,immunosuppressive or immune modulating therapies Macular Edema Life expectancy of less than 90 days due to comorbid conditions Occurrences of secondary intracerebral hemorrhage/ischemic stroke Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, noncompliance, living in another state or any other cause

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: young Fresh Frozen Plasma<br>Drug: young plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset. Drug: young plasma exchange over a course of 3 consecutive days after stroke onset. | Drug: young Fresh Frozen Plasma<br>* Blood plasma from healthy male donors aged 18-30 years old.<br>|
| Placebo Comparator: old Fresh Frozen Plasma<br>Old plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset. Old plasma exchange over a course of 3 consecutive days after stroke onset. Patients will receive usual care and drug use in hospital. | Drug: old Fresh Frozen Plasma<br>* Blood plasma from healthy male donors aged 40-55 years old.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in National Institutes of Health Stroke Scale (NIHSS) | describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days | up to 90 days | 
| Changes in modified Barthel Index | describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days | up to 90 days | 
| Changes in modified Rankin Scale | describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days | up to 90 days | 
| Changes in Glasgow coma scale | describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hematoma volume |  | At baseline, 7 days, 14 days and 30 days after the onset | 
| Change in peripheral edema volume |  | At baseline, 7 days, 14 days and 30 days after the onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute stroke, young health plasma, efficacy, safety