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Completed

NCT Number: NCT03242525

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

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.

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Key information

Conditions

Blood Analysis, Event History Point-of-Care Systems

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years

Exclusion criteria

  • Missing written consent
  • Withdrawal

Treatment and study plan

POCT and central laboratory blood analysis

Diagnostic Test

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

Primary outcomes

  1. Time advantage

    Time frame: 2-4 hours

    Duration until laboratory results are available after sampling for central laboratory versus POCT

Secondary outcomes

  1. Correlation between central laboratory and POCT results.

    Time frame: 2-4 hours

    Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis.

  2. Influence of transport type.

    Time frame: 2-4 hours

    Difference of results availability weather probes are transported by transport service or tube-mail.

  3. Influence of daytime and weekday on results availability.

    Time frame: 2-4 hours

    Difference of results availability in dependence of daytime and weekday on transport duration.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 8, 2017
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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