Prognostic Value of Plasma Thrombospondin-1 Levels After... | NCT02465671

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

NCT02465671

Sponsor

Jinhua People's Hospital

Status

Completed

Last Update Posted

Jun 8, 2015Estimated

Enrollment

110Actual

Phase

Not provided

Conditions

Cerebral Hemorrhage

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Aug 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jun 4, 2015

First Submission Date that Met QC Criteria

Jun 4, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2015

Last Update Posted Date

Jun 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality after intracerebral hemorrhage		Follow-up of 6 months

Secondary Outcomes

Measure	Description	Time Frame
Unfavorable outcome (modified Rankin Scale score >2 )		Follow-up of 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Zhen-Yu CHENG	Jinhua People's Hospital	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

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Browse Branches

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