Comparison of POC-test-equipment With the Laboratory

NCT ID: NCT02042417

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Including criteria: ICU-patients from 18-99 years

Conditions

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INR-POC-testing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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INRatio2 and CoaguChek

one measuring per tool, in case of error: one repetiton

Group Type EXPERIMENTAL

INRatio2 and CoaguChek

Intervention Type DEVICE

Interventions

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INRatio2 and CoaguChek

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

18-99 years, ICU patients

Exclusion Criteria

Lupus erythematodes Anti-Phospholipid-Antikörper
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Reinhard Hahn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MUVienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Central Contacts

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Reinhard Hahn, MD

Role: CONTACT

+431 40400

Facility Contacts

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Reinhard Hahn, MD

Role: primary

+43 1 40400

Nitaya Lebl

Role: backup

Other Identifiers

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INRatio_CoaguChek

Identifier Type: -

Identifier Source: org_study_id

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