NCT00867646

Brief Summary

Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

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

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

3 months

First QC Date

August 1, 2008

Last Update Submit

December 14, 2009

Conditions

Deep Vein Thrombosis

Keywords

PTDVT

Outcome Measures

Primary Outcomes (1)

  • Comparison of the PTINR measured by Coaguchek and laboratory CA1500

    2 Months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

70 Warfarin teated patients

You may qualify if:

  • Warfarin continuously treated patients

You may not qualify if:

  • Warfarin recently discontinuous treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Chiang Fu-Tien, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2008

First Posted

March 24, 2009

Study Start

May 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

TW(1)