NCT01759433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

November 29, 2012

Last Update Submit

December 28, 2013

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • The reference intervals for sonoclot analysis in Chinese

    whether Chinese reference intervals are different from Caucasian reference intervals.

    3 month

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese healthy adults aged 18 and older

You may qualify if:

  • Aged 18 and older
  • Han ethnic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Asia Heart hospital

Wuhan, Hubei, 430022, China

Location

Biospecimen

Retention: NONE RETAINED

2.7 mL citrated blood.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the clinical laboratory

Study Record Dates

First Submitted

November 29, 2012

First Posted

January 3, 2013

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

CN(1)