Efficacy and Safety of Young Health Plasma on Acute Stroke

NCT ID: NCT02913183

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-10-31

Brief Summary

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

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

young Fresh Frozen Plasma

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.

Group Type: EXPERIMENTAL

young Fresh Frozen Plasma

Intervention Type: DRUG

Blood plasma from healthy male donors aged 18-30 years old.

old Fresh Frozen Plasma

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.

Group Type: PLACEBO_COMPARATOR

old Fresh Frozen Plasma

Intervention Type: DRUG

Blood plasma from healthy male donors aged 40-55 years old.

Interventions

young Fresh Frozen Plasma

Blood plasma from healthy male donors aged 18-30 years old.

Intervention Type: DRUG

old Fresh Frozen Plasma

Blood plasma from healthy male donors aged 40-55 years old.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Yi Xiong

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qing-Wu Yang, MD,PhD

Role: CONTACT

yangqwmlys@hotmail.com

Xiao-Yi Xiong, MD,PhD

Role: CONTACT

xiongxy1989@hotmail.com

Other Identifiers

XinqiaoH-01

Identifier Type: -

Identifier Source: org_study_id