Comparison of POC-test-equipment With the Laboratory

Phase 4

• Conditions: INR-POC-testing
• Interventions: Device: INRatio2 and CoaguChek

• Registration Number: NCT02042417
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Including criteria: ICU-patients from 18-99 years

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Last Update Submitted: 2014-01-20
• Study First Posted: 2014-01-22
• Last Update Posted: 2014-01-22
• Study Start: 2014-02
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

18-99 years, ICU patients

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Exclusion Criteria

Lupus erythematodes Anti-Phospholipid-Antikörper

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INRatio2 and CoaguChek	INRatio2 and CoaguChek	one measuring per tool, in case of error: one repetiton

Primary Outcome Measures

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

Trial Locations

Locations (1)

MUVienna; 🇦🇹 Vienna, Austria