Efficacy and Safety of Young Health Plasma on Acute Stroke

NCT02913183 | Unknown Phase 2 DMC

• 1 other identifier: XinqiaoH-01
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

acute stroke; young health plasma; efficacy; safety

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

young Fresh Frozen Plasma

EXPERIMENTAL

1. Drug: young plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset. 2. Drug: young plasma exchange over a course of 3 consecutive days after stroke onset.

Drug: young Fresh Frozen Plasma

old Fresh Frozen Plasma

PLACEBO COMPARATOR

1. Old plasma will be administered as 2 unit /day over a course of 3 consecutive days after stroke onset. 2. Old plasma exchange over a course of 3 consecutive days after stroke onset. 3. Patients will receive usual care and drug use in hospital.

Drug: old Fresh Frozen Plasma

Interventions

young Fresh Frozen Plasma DRUG

Blood plasma from healthy male donors aged 18-30 years old.

young Fresh Frozen Plasma

old Fresh Frozen Plasma DRUG

Blood plasma from healthy male donors aged 40-55 years old.

old Fresh Frozen Plasma

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qing-Wu Yang, MD,PhD

CONTACT

yangqwmlys@hotmail.com

Xiao-Yi Xiong, MD,PhD

CONTACT

xiongxy1989@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: September 23, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share