Clinical trial NCT02913183: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Keywords: acute stroke
young health plasma
efficacy
safety
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in National Institutes of Health Stroke Scale (NIHSS)
timeFrame: up to 90 days
measure: Changes in modified Barthel Index
timeFrame: up to 90 days
measure: Changes in modified Rankin Scale
timeFrame: up to 90 days
measure: Changes in Glasgow coma scale
timeFrame: up to 90 days
Secondary outcomes:
measure: Changes in hematoma volume
timeFrame: At baseline, 7 days, 14 days and 30 days after the onset
measure: Change in peripheral edema volume
timeFrame: At baseline, 7 days, 14 days and 30 days after the onset
Other outcomes:
Locations:
Study officials:
References: