NCT02913183

Efficacy and Safety of Young Health Plasma on Acute Stroke

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-09-23
• Last updated: 2016-09-23