Efficacy and Safety of Young Health Plasma on Acute Stroke

Stroke Clinical Trial

Official title:

Efficacy and Safety of Young Health Plasma on Acute Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02913183
• Other study ID #: XinqiaoH-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 11, 2016
• Last updated: September 21, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: September 2016
• Source: Xinqiao Hospital of Chongqing
• Contact: Qing-Wu Yang, MD,PhD
• Email: yangqwmlys[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Chongqing City
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• young Fresh Frozen Plasma
Blood plasma from healthy male donors aged 18-30 years old.
• old Fresh Frozen Plasma
Blood plasma from healthy male donors aged 40-55 years old.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Changes in modified Barthel Index	describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days	up to 90 days	Yes
Primary	Changes in modified Rankin Scale	describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days	up to 90 days	Yes
Primary	Changes in Glasgow coma scale	describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days	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