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Efficacy and Safety of Young Health Plasma on Acute Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
young Fresh Frozen Plasma
old Fresh Frozen Plasma
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring acute stroke, young health plasma, efficacy, safety

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    young Fresh Frozen Plasma

    old Fresh Frozen Plasma

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in National Institutes of Health Stroke Scale (NIHSS)
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
    Changes in modified Barthel Index
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
    Changes in modified Rankin Scale
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
    Changes in Glasgow coma scale
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days

    Secondary Outcome Measures

    Changes in hematoma volume
    Change in peripheral edema volume

    Full Information

    First Posted
    September 11, 2016
    Last Updated
    September 21, 2016
    Sponsor
    Xinqiao Hospital of Chongqing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02913183
    Brief Title
    Efficacy and Safety of Young Health Plasma on Acute Stroke
    Official Title
    Efficacy and Safety of Young Health Plasma on Acute Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xinqiao Hospital of Chongqing

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    acute stroke, young health plasma, efficacy, safety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    young Fresh Frozen Plasma
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    old Fresh Frozen Plasma
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    young Fresh Frozen Plasma
    Intervention Description
    Blood plasma from healthy male donors aged 18-30 years old.
    Intervention Type
    Drug
    Intervention Name(s)
    old Fresh Frozen Plasma
    Intervention Description
    Blood plasma from healthy male donors aged 40-55 years old.
    Primary Outcome Measure Information:
    Title
    Changes in National Institutes of Health Stroke Scale (NIHSS)
    Description
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
    Time Frame
    up to 90 days
    Title
    Changes in modified Barthel Index
    Description
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
    Time Frame
    up to 90 days
    Title
    Changes in modified Rankin Scale
    Description
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
    Time Frame
    up to 90 days
    Title
    Changes in Glasgow coma scale
    Description
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
    Time Frame
    up to 90 days
    Secondary Outcome Measure Information:
    Title
    Changes in hematoma volume
    Time Frame
    At baseline, 7 days, 14 days and 30 days after the onset
    Title
    Change in peripheral edema volume
    Time Frame
    At baseline, 7 days, 14 days and 30 days after the onset

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qing-Wu Yang, MD,PhD
    Email
    yangqwmlys@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiao-Yi Xiong, MD,PhD
    Email
    xiongxy1989@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Neurofunctional assessment including NIHSS, modified Barthel Index, modified Rankin Scale,and Glasgow coma scale, hematoma volume,and peripheral edema volume are to be shared.

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    Efficacy and Safety of Young Health Plasma on Acute Stroke

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