Cerebral HemorrhageNCT02465671
Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage
An observational study of Cerebral Hemorrhage, run by Jinhua People's Hospital.
Trial summary
The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Hemorrhage
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Feb 2013
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke were enrolled.
Who may be able to join
- acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke.
Who cannot join
- previous ischemic or hemorrhagic stroke, severe head trauma, use of antiplatelet or anticoagulant medication, presence of other prior systemic diseases including autoimmune diseases, uremia, liver cirrhosis, malignancy, and chronic heart or lung disease, recent infection (within a month), a surgical procedure and missing of follow-up.
About this study
Official title: Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage：A Pilot Study
The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage.
Read the detailed description
Thrombospondin-1 acts as an anti-angiogenic factor and its expression in rat brain is upregulated after intracerebral hemorrhage. The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage. About 110 patients will be recruited. All blood samples from the patients at admission were collected. Thrombospondin-1 levels in plasma were measured using sandwich immunoassays. The patients will be followed up till 6 months after intracerebral hemorrhage. The relationships between plasma thrombospondin-1 levels and 1-week mortality, 6-month mortality, 6-month overall survival, 6-month unfavorable outcome (modified Rankin Scale score >2) and disease severity reflected by hematoma volume and National Institutes of Health Stroke Scale score were assessed using multivariate analysis. It is proposed that elevated plasma thrombospondin-1 levels are independently associated with disease severity and clinical outcomes. It will be suggested thrombospondin has potential to be a good prognostic biomarker of intracerebral hemorrhage.
- Conditions
- Cerebral Hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients group | All patients with acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke during the same period were enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality after intracerebral hemorrhage
Measured: Follow-up of 6 months
Secondary outcomes (1)
Unfavorable outcome (modified Rankin Scale score >2 )
Measured: Follow-up of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinhua People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhen-Yu CHENG, Study chair, Jinhua People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465671
- Sponsor's protocol ID
- Jhh2015024
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage：A Pilot Study
- ClinicalTrials.gov ID
- NCT02465671
- Acronym / sponsor ID
- Jhh2015024
- Conditions
- Cerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jinhua People's HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Jun 2015 (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.
The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage.
Detailed description
Thrombospondin-1 acts as an anti-angiogenic factor and its expression in rat brain is upregulated after intracerebral hemorrhage. The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage. About 110 patients will be recruited. All blood samples from the patients at admission were collected. Thrombospondin-1 levels in plasma were measured using sandwich immunoassays. The patients will be followed up till 6 months after intracerebral hemorrhage. The relationships between plasma thrombospondin-1 levels and 1-week mortality, 6-month mortality, 6-month overall survival, 6-month unfavorable outcome (modified Rankin Scale score >2) and disease severity reflected by hematoma volume and National Institutes of Health Stroke Scale score were assessed using multivariate analysis. It is proposed that elevated plasma thrombospondin-1 levels are independently associated with disease severity and clinical outcomes. It will be suggested thrombospondin has potential to be a good prognostic biomarker of intracerebral hemorrhage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | –All patients with acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke during the same period were enrolled. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke were enrolled.
Key inclusion criteria (1 listed)
- acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke.
Key exclusion criteria (1 listed)
- previous ischemic or hemorrhagic stroke, severe head trauma, use of antiplatelet or anticoagulant medication, presence of other prior systemic diseases including autoimmune diseases, uremia, liver cirrhosis, malignancy, and chronic heart or lung disease, recent infection (within a month), a surgical procedure and missing of follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality after intracerebral hemorrhage
Time frame: Follow-up of 6 months
1 secondary outcome
Unfavorable outcome (modified Rankin Scale score >2 )
Time frame: Follow-up of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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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.
Zhen-Yu CHENG study chair
Jinhua People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hemorrhage, run by Jinhua People's Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jun 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality after intracerebral hemorrhage (time frame: Follow-up of 6 months). 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 8 Jun 2015.