StrokePhase 2NCT02913183
Efficacy and Safety of Young Health Plasma on Acute Stroke
A Phase 2 study testing young Fresh Frozen Plasma and old Fresh Frozen Plasma in people with Stroke, run by Xinqiao Hospital of Chongqing.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- young Fresh Frozen Plasma and old Fresh Frozen Plasma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
Qing-Wu Yang, MD,PhD contact
Xiao-Yi Xiong, MD,PhD contact
About this study
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.
Read the 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
- Being tested
- young Fresh Frozen Plasma, old Fresh Frozen Plasma
- Keywords
- acute stroke, young health plasma, efficacy, safety
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
young Fresh Frozen PlasmaDrug
Blood plasma from healthy male donors aged 18-30 years old.
old Fresh Frozen PlasmaDrug
Blood plasma from healthy male donors aged 40-55 years old.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: old Fresh Frozen Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in National Institutes of Health Stroke Scale (NIHSS)
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Measured: up to 90 days
Changes in modified Barthel Index
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Measured: up to 90 days
Changes in modified Rankin Scale
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Measured: up to 90 days
Changes in Glasgow coma scale
describe the clinical improvement at baseline, 7 days, 14 days, 30 days and 90 days
Measured: up to 90 days
Secondary outcomes (2)
Changes in hematoma volume
Measured: At baseline, 7 days, 14 days and 30 days after the onset
Change in peripheral edema volume
Measured: At baseline, 7 days, 14 days and 30 days after the onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Yi Xiong, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913183
- Sponsor's protocol ID
- XinqiaoH-01
- Status last verified
- Sep 2016
- First submitted
- 11 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Neurofunctional assessment including NIHSS, modified Barthel Index, modified Rankin Scale,and Glasgow coma scale, hematoma volume,and peripheral edema volume are to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Young Health Plasma on Acute Stroke
- ClinicalTrials.gov ID
- NCT02913183
- Acronym / sponsor ID
- XinqiaoH-01
- Conditions
- Stroke
- Keywords
- acute stroke, young health plasma, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young Fresh Frozen Plasma | Experimental | Drug: young Fresh Frozen Plasma1. 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. |
| old Fresh Frozen Plasma | Placebo comparator | Drug: old Fresh Frozen Plasma1. 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| young Fresh Frozen PlasmaBlood plasma from healthy male donors aged 18-30 years old. | Drug | young Fresh Frozen Plasma |
| old Fresh Frozen PlasmaBlood plasma from healthy male donors aged 40-55 years old. | Drug | old Fresh Frozen Plasma |
Primary outcome
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
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
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
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
2 secondary outcomes
Changes in hematoma volume
Time frame: At baseline, 7 days, 14 days and 30 days after the onset
Change in peripheral edema volume
Time frame: At baseline, 7 days, 14 days and 30 days after the onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing-Wu Yang, MD,PhD contact
Xiao-Yi Xiong, MD,PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing young Fresh Frozen Plasma and old Fresh Frozen Plasma in people with Stroke, run by Xinqiao Hospital of Chongqing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing-Wu Yang, MD,PhD (yangqwmlys@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in National Institutes of Health Stroke Scale (NIHSS) (time frame: up to 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.