Efficacy and Safety of Young Health Plasma on Acute Stroke

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Drug: young Fresh Frozen Plasma; Drug: old Fresh Frozen Plasma

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: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: young Fresh Frozen Plasma; 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; Blood plasma from healthy male donors aged 18-30 years old.
PLACEBO_COMPARATOR: old Fresh Frozen Plasma; 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; Blood plasma from healthy male donors aged 40-55 years old.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: September 11, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (ESTIMATE): September 23, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: safety; efficacy; acute stroke; young health plasma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: XinqiaoH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.