Reference Intervals for Sonoclot Analysis in Chinese | NCT01759433

Studies
Reference Intervals for Sonoclot Analysis in Chinese

NCT01759433

Sponsor

Wuhan Asia Heart Hospital

Status

Completed

Last Update Posted

Dec 31, 2013Estimated

Enrollment

135Actual

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

Not provided

Countries

China

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

Dec 2013

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

Dec 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Nov 29, 2012

First Submission Date that Met QC Criteria

Dec 30, 2012

First Posted Date

Jan 3, 2013Estimated

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

Dec 28, 2013

Last Update Posted Date

Dec 31, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhenlu Zhang, Director of the clinical laboratory, Wuhan Asia Heart HospitalPrincipal Investigator

Lead Sponsor

Wuhan Asia Heart HospitalOTHER

Collaborators

Not provided

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 reference intervals for Sonoclot Analysis may be different between Chinese and American. So far, no reference interval has been established in Chinese for Sonoclot Analysis. This study is going to establish the first Chinese reference intervals for Sonoclot Analysis and test whether they are different from American reference intervals.

Detailed Description

Not provided

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

135Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The reference intervals for sonoclot analysis in Chinese	whether Chinese reference intervals are different from Caucasian reference intervals.	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 and older
Han ethnic

Exclusion Criteria:

Renal dysfunction
Liver disorders
Known coagulation disorders
Patients taking medications in the last month

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

Chinese healthy adults aged 18 and older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan Asia Heart hospital		Wuhan	Hubei	430022	China

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided