Evaluation of the Validity of the Prothrombin Time Internation Normalised Ratio (PT/INR) Measured at the point-of Care on the Arterial Bloodline of Haemodialysis Extracorporeal Blood Flow (COAGHEMO)

September 13, 2016 updated by: University Hospital, Brest
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • Recruiting
        • CHU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation ratio between point-of-care PT/INR value and standard laboratory assessement
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • COAGHEMO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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