NCT02902848

Brief Summary

The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation state (prothrombin time) measured inside the therapeutical zone and thanks to a portable monitor. The values obtained at the point of care will be compared to the standard biological assessment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 8, 2016

Last Update Submit

September 13, 2016

Conditions

Haemodialysis

Outcome Measures

Primary Outcomes (1)

  • correlation ratio between point-of-care PT/INR value and standard laboratory assessement

    5 months

Eligibility Criteria

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

The population of the study is the patients under haemodialysis treatment, who need INR monitoring

You may qualify if:

  • Age \> 18
  • Haemodialyzed patient whose INR needs to be monitored
  • Patient not objecting to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brest

Brest, 29200, France

RECRUITING

Central Study Contacts

Yannick Le meur, MD-PhD

CONTACT

yannick.lemeur@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 16, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

FR(1)