Comparison of POC-test-equipment With the Laboratory | NCT02042417

Studies
Comparison of POC-test-equipment With the Laboratory

NCT02042417

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Jan 22, 2014Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

INR-POC-testing

Interventions

INRatio2 and CoaguChek

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Jan 20, 2014

First Submission Date that Met QC Criteria

Jan 20, 2014

First Posted Date

Jan 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2014

Last Update Posted Date

Jan 22, 2014Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INRatio2 and CoaguChek	Experimental	one measuring per tool, in case of error: one repetiton	Device: INRatio2 and CoaguChek

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INRatio2 and CoaguChek	Device		INRatio2 and CoaguChek

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-99 years, ICU patients

Exclusion Criteria:

Lupus erythematodes Anti-Phospholipid-Antikörper

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reinhard Hahn, MD	Contact	+431 40400		reinhard.hahn@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUVienna		Vienna	State of Vienna	1090	Austria