NCT01375725

Brief Summary

The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
Last Updated

June 17, 2011

Status Verified

June 1, 2011

Enrollment Period

Same day

First QC Date

June 15, 2011

Last Update Submit

June 16, 2011

Conditions

Clotting Disorders

Outcome Measures

Primary Outcomes (1)

  • PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device

    To determine the correlation of PT/INR values between an experimental and commercial device

    Five days to collect data and up to two weeks to generate correlation graph

Study Arms (1)

Coumadin (warfarin)

Subjects currently receiving coumadin (warfarin) treatment.

Eligibility Criteria

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

Subjects currently receiving coumadin (warfarin) treatment

You may qualify if:

  • Are currently taking coumadin (warfarin)
  • Are aged 18 years or older
  • Able and willing to provide informed consent
  • Can understand (read and write) English
  • Required to provide a capillary sample as part of their routine medical check

You may not qualify if:

  • Previously participated in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

White River Diagnostic Clinic

Batesville, Arkansas, 72501, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Richard Ward, Pharm.D

    Harding University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 17, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 17, 2011

Record last verified: 2011-06

Locations

US(1)