Efficacy and Safety of Young Health Plasma on Acute Stroke

Not yet recruiting

Phase 2 Results N/A

Trial Description

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

Interventions

  • Young Fresh Frozen Plasma Drug
    Intervention Desc: Blood plasma from healthy male donors aged 18-30 years old.
    ARM 1: Kind: Experimental
    Label: young Fresh Frozen Plasma
    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 Fresh Frozen Plasma Drug
    Intervention Desc: Blood plasma from healthy male donors aged 40-55 years old.
    ARM 1: Kind: Experimental
    Label: old Fresh Frozen Plasma
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in National Institutes of Health Stroke Scale (NIHSS) up to 90 days Yes
Primary Changes in modified Barthel Index up to 90 days Yes
Primary Changes in modified Rankin Scale up to 90 days Yes
Primary Changes in Glasgow coma scale up to 90 days Yes
Secondary Changes in hematoma volume At baseline, 7 days, 14 days and 30 days after the onset No
Secondary Change in peripheral edema volume At baseline, 7 days, 14 days and 30 days after the onset No

Sponsors