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

March 17, 2019 updated by: Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All bleeding patients assigned to the emergency department and delivery room.

Description

Inclusion Criteria:

  • Age > 18 years

Exclusion Criteria:

  • Missing written consent
  • Withdrawal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency room
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
In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.
Delivery room
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
In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time advantage
Time Frame: 2-4 hours
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.
Time Frame: 2-4 hours
Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis.
2-4 hours
Influence of transport type.
Time Frame: 2-4 hours
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.
Time Frame: 2-4 hours
Difference of results availability in dependence of daytime and weekday on transport duration.
2-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Study Director: Kai Zacharowski, Prof. Dr., Department of Anesthesia, Intensive Care Medicine and Pain Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 26, 2017

Primary Completion (ACTUAL)

November 30, 2018

Study Completion (ACTUAL)

February 28, 2019

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (ACTUAL)

August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 279/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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