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Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT02465671
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Jinhua People's Hospital

Brief 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.

Condition or disease
Cerebral 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.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage:A Pilot Study
Study Start Date : August 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort
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.



Primary Outcome Measures :
  1. mortality after intracerebral hemorrhage [ Time Frame: Follow-up of 6 months ]

Secondary Outcome Measures :
  1. Unfavorable outcome (modified Rankin Scale score >2 ) [ Time Frame: Follow-up of 6 months ]

Biospecimen Retention:   Samples Without DNA
All blood samples from the patients at admission were collected in the separator tubes and centrifuged within 30 minutes at 1,000*g for 15 minutes. The plasma was removed and frozen at -70°C until measurement.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465671


Sponsors and Collaborators
Jinhua People's Hospital
Investigators
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Study Chair: Zhen-Yu CHENG Jinhua People's Hospital

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Responsible Party: Jinhua People's Hospital
ClinicalTrials.gov Identifier: NCT02465671     History of Changes
Other Study ID Numbers: Jhh2015024
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases