Comparison of POC-test-equipment With the Laboratory

INR-POC-testing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02042417
• Other study ID #: INRatio_CoaguChek
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 20, 2014
• Last updated: January 20, 2014
• Start date: February 2014

Study information

• Verified date: January 2014
• Source: Medical University of Vienna
• Contact: Reinhard Hahn, MD
• Phone: +431 40400
• Email: reinhard.hahn[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

Including criteria: ICU-patients from 18-99 years

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

18-99 years, ICU patients

Exclusion Criteria:

Lupus erythematodes Anti-Phospholipid-Antikörper

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• INR-POC-testing

Intervention

Device:
• INRatio2 and CoaguChek

Locations

Country	Name	City	State
Austria	MUVienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of POC-test-equipment with the standard method (laboratory) at ICU-patients	outcome measure: Bland Altman plot	12 months	No