Efficacy and Safety of Young Health Plasma on Acute Stroke

Army Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Stroke

Treatments: Drug: old Fresh Frozen Plasma; Drug: young Fresh Frozen Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02913183

XinqiaoH-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups, including a placebo group

young Fresh Frozen Plasma

Experimental group

Description:

1. Drug: young plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset. 2. Drug: young plasma exchange over a course of 3 consecutive days after stroke onset.

Treatment:

Drug: young Fresh Frozen Plasma

old Fresh Frozen Plasma

Placebo Comparator group

Description:

1. Old plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset. 2. Old plasma exchange over a course of 3 consecutive days after stroke onset. 3. Patients will receive usual care and drug use in hospital.

Treatment:

Drug: old Fresh Frozen Plasma