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

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: Point-of-Care Systems; Blood; Analysis, Event History
• Intervention / Treatment: Diagnostic test: POCT and central laboratory blood analysis

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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

Collaborators and Investigators

• 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

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