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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: POCT and central laboratory blood analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Exclusion Criteria: Missing written consent Withdrawal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emergency room<br>Twelve bleeding patients who are assigned to the emergency department receive a simultaneous blood analysis with POCT and central laboratory. | Diagnostic Test: POCT and central laboratory blood analysis<br>* In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.<br>|
| Delivery room<br>Twelve bleeding patients who are assigned to the delivery room receive a simultaneous blood analysis with POCT and central laboratory. | Diagnostic Test: POCT and central laboratory blood analysis<br>* In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time advantage | Duration until laboratory results are available after sampling for central laboratory versus POCT | 2-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between central laboratory and POCT results. | Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis. | 2-4 hours | 
| Influence of transport type. | Difference of results availability weather probes are transported by transport service or tube-mail. | 2-4 hours | 
| Influence of daytime and weekday on results availability. | Difference of results availability in dependence of daytime and weekday on transport duration. | 2-4 hours |