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Efficacy and Safety of Young Health Plasma on Acute Stroke

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ClinicalTrials.gov Identifier: NCT02913183
Recruitment Status : Unknown
Verified September 2016 by Xiao-Yi Xiong, Xinqiao Hospital of Chongqing.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Xiao-Yi Xiong, Xinqiao Hospital of Chongqing

Tracking Information
First Submitted Date  ICMJE September 11, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Changes in National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: up to 90 days ]
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
  • Changes in modified Barthel Index [ Time Frame: up to 90 days ]
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
  • Changes in modified Rankin Scale [ Time Frame: up to 90 days ]
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
  • Changes in Glasgow coma scale [ Time Frame: up to 90 days ]
    describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Changes in hematoma volume [ Time Frame: At baseline, 7 days, 14 days and 30 days after the onset ]
  • Change in peripheral edema volume [ Time Frame: At baseline, 7 days, 14 days and 30 days after the onset ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Young Health Plasma on Acute Stroke
Official Title  ICMJE Efficacy and Safety of Young Health Plasma on Acute Stroke
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Drug: young Fresh Frozen Plasma
    Blood plasma from healthy male donors aged 18-30 years old.
  • Drug: old Fresh Frozen Plasma
    Blood plasma from healthy male donors aged 40-55 years old.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: young Fresh Frozen Plasma
  • Placebo Comparator: 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.
    Intervention: Drug: old Fresh Frozen Plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913183
Other Study ID Numbers  ICMJE XinqiaoH-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Responsible Party Xiao-Yi Xiong, Xinqiao Hospital of Chongqing
Study Sponsor  ICMJE Xinqiao Hospital of Chongqing
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xinqiao Hospital of Chongqing
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP