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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03242525
Other study ID # 279/17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2017
Est. completion date February 28, 2019

Study information

Verified date March 2019
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 28, 2019
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

Exclusion Criteria:

- Missing written consent

- Withdrawal

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany University Hospital Frankfurt Frankfurt am Main Hessen

Sponsors (1)

Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time advantage Duration until laboratory results are available after sampling for central laboratory versus POCT 2-4 hours
Secondary Correlation between central laboratory and POCT results. Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis. 2-4 hours
Secondary Influence of transport type. Difference of results availability weather probes are transported by transport service or tube-mail. 2-4 hours
Secondary Influence of daytime and weekday on results availability. Difference of results availability in dependence of daytime and weekday on transport duration. 2-4 hours
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