Comparison of POC-test-equipment With the Laboratory

January 20, 2014 updated by: Reinhard Hahn, Medical University of Vienna

Comparison of POC-test-equipment With the Standard Method (Laboratory) at ICU-patients

We compare two POC-tests (INRario2 and CoaguChek) for the INR with the laboratory. Therefore, we take bloodsamples (capillary and venous blood) and put it on the tool. After the measuring, a number is shown = INR.

We develop a Bland-Altman-plot for the correlation between the tool value and the laboratory value to illustrate the applicability in the clinical daily routine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Including criteria: ICU-patients from 18-99 years

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

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

Description

Inclusion Criteria:

18-99 years, ICU patients

Exclusion Criteria:

Lupus erythematodes Anti-Phospholipid-Antikörper

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INRatio2 and CoaguChek
one measuring per tool, in case of error: one repetiton
Device: INRatio2 and CoaguChek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of POC-test-equipment with the standard method (laboratory) at ICU-patients
Time Frame: 12 months
outcome measure: Bland Altman plot
12 months

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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

February 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • INRatio_CoaguChek

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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