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

Completed

• Conditions: Cerebral Hemorrhage

• Registration Number: NCT02465671
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-08
• Primary Completion: 2012-08
• Study Completion: 2013-02
• Status Verified: 2015-06
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-04
• Last Update Submitted: 2015-06-04
• Study First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality after intracerebral hemorrhage	Follow-up of 6 months

Secondary Outcome Measures

Name	Time	Method
Unfavorable outcome (modified Rankin Scale score >2 )	Follow-up of 6 months