Examination of the Time Advantage Between POCT and Conventional Central Laboratory Analysis

Analysis, Event History Clinical Trial

Official title:

Examination of the Time Advantage of Point of Care Testing (POCT) Compared to the Conventional Central Laboratory Analysis in Intraclinical Patient Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242525
• Other study ID #: 279/17
• Status: Completed
• Start date: October 26, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present study is to quantify the time advantage achieved by the use of POCT compared to conventional coagulation diagnostics. A further objective of this study is an analysis of the result quality of POCT for the prothrombin time / international normalized ratio.

Description:

In order to be able to carry out a targeted coagulation therapy for the time-critical treatment of coagulopathic emergency patients, knowledge of the hemostatic potential is necessary.

After taking blood samples for coagulation diagnostics, they are sent to the central laboratory. After the analysis and validation the electronic provision of the results takes place. The loss of time by sample transport, analysis and breadth of the results extends the duration until therapy can be started.

The period of time until these analysis results are determined depends on several factors like daytime, day of week and location of the sample consignor and the availability of the laboratory. Not every clinic is connected to an internal tube mail system so that the samples have to be sent partly with a transport service.

In recent years, Point of Care (POCT) devices have become an increasingly important tool for diagnosing coagulopathic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 28, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

Exclusion Criteria:

• Missing written consent

• Withdrawal

Related Conditions & MeSH terms

• Analysis, Event History
• Blood
• Point-of-Care Systems

Intervention

Diagnostic Test:
• POCT and central laboratory blood analysis
In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time advantage	Duration until laboratory results are available after sampling for central laboratory versus POCT	2-4 hours
Secondary	Correlation between central laboratory and POCT results.	Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis.	2-4 hours
Secondary	Influence of transport type.	Difference of results availability weather probes are transported by transport service or tube-mail.	2-4 hours
Secondary	Influence of daytime and weekday on results availability.	Difference of results availability in dependence of daytime and weekday on transport duration.	2-4 hours