Efficacy and Safety of Young Health Plasma on Acute Stroke

• ClinicalTrials.gov Identifier: NCT02913183
• Recruitment Status: Unknown
• First Posted: September 23, 2016
• Last Update Posted: September 23, 2016
• Sponsor: Xinqiao Hospital of Chongqing
• Information provided by (Responsible Party): Xiao-Yi Xiong, Xinqiao Hospital of Chongqing

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Drug: young Fresh Frozen Plasma; Drug: old Fresh Frozen Plasma	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Young Health Plasma on Acute Stroke
• Study Start Date: October 2016
• Estimated Primary Completion Date: October 2017
• Estimated Study Completion Date: October 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: young Fresh Frozen Plasma; 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.	Drug: young Fresh Frozen Plasma; Blood plasma from healthy male donors aged 18-30 years old.
Placebo Comparator: old Fresh Frozen Plasma; 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.	Drug: old Fresh Frozen Plasma; Blood plasma from healthy male donors aged 40-55 years old.

Outcome Measures

Primary Outcome Measures :

1. Changes in National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: up to 90 days ]
   describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
2. Changes in modified Barthel Index [ Time Frame: up to 90 days ]
   describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
3. Changes in modified Rankin Scale [ Time Frame: up to 90 days ]
   describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
4. Changes in Glasgow coma scale [ Time Frame: up to 90 days ]
   describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days

Secondary Outcome Measures :

1. Changes in hematoma volume [ Time Frame: At baseline, 7 days, 14 days and 30 days after the onset ]
2. Change in peripheral edema volume [ Time Frame: At baseline, 7 days, 14 days and 30 days after the onset ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 80 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Qing-Wu Yang, MD,PhD; yangqwmlys@hotmail.com

Contact: Xiao-Yi Xiong, MD,PhD; xiongxy1989@hotmail.com

Sponsors and Collaborators

Xinqiao Hospital of Chongqing

More Information

• Responsible Party: Xiao-Yi Xiong, Medical Doctor, Xinqiao Hospital of Chongqing
• ClinicalTrials.gov Identifier: NCT02913183 History of Changes
• Other Study ID Numbers: XinqiaoH-01
• First Posted: September 23, 2016
• Last Update Posted: September 23, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Neurofunctional assessment including NIHSS, modified Barthel Index, modified Rankin Scale,and Glasgow coma scale, hematoma volume,and peripheral edema volume are to be shared.

Keywords provided by Xiao-Yi Xiong, Xinqiao Hospital of Chongqing:

acute stroke; young health plasma; efficacy; safety

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases