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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03242525
Enrollment
24
Registered
2017-08-08
Start date
2017-10-26
Completion date
2019-02-28
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTPOCT and central laboratory blood analysis

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

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \> 18 years

Exclusion criteria

* Missing written consent * Withdrawal

Design outcomes

Primary

MeasureTime frameDescription
Time advantage2-4 hoursDuration until laboratory results are available after sampling for central laboratory versus POCT

Secondary

MeasureTime frameDescription
Correlation between central laboratory and POCT results.2-4 hoursCorrelation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis.
Influence of transport type.2-4 hoursDifference of results availability weather probes are transported by transport service or tube-mail.
Influence of daytime and weekday on results availability.2-4 hoursDifference of results availability in dependence of daytime and weekday on transport duration.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026