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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| young Fresh Frozen Plasma | Experimental |
|
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| old Fresh Frozen Plasma | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| young Fresh Frozen Plasma | Drug | Blood plasma from healthy male donors aged 18-30 years old. |
|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing-Wu Yang, MD,PhD | Contact | yangqwmlys@hotmail.com | ||
| Xiao-Yi Xiong, MD,PhD | Contact | xiongxy1989@hotmail.com |
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Neurofunctional assessment including NIHSS, modified Barthel Index, modified Rankin Scale,and Glasgow coma scale, hematoma volume,and peripheral edema volume are to be shared.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| old Fresh Frozen Plasma | Drug | Blood plasma from healthy male donors aged 40-55 years old. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |