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

Cerebral Hemorrhage Clinical Trial

Official title:

Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage：A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465671
• Other study ID #: Jhh2015024
• Status: Completed
• Phase: N/A
• First received: June 4, 2015
• Last updated: June 4, 2015
• Start date: August 2010
• Est. completion date: February 2013

Study information

• Verified date: June 2015
• Source: Jinhua People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Zhejiang Province
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jinhua People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality after intracerebral hemorrhage		Follow-up of 6 months	Yes
Secondary	Unfavorable outcome (modified Rankin Scale score >2 )		Follow-up of 6 months	Yes