NCT03242525

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

August 4, 2017

Last Update Submit

March 17, 2019

Conditions

BloodPoint-of-Care SystemsAnalysis, Event History

Outcome Measures

Primary Outcomes (1)

  • Time advantage

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

    2-4 hours

Secondary Outcomes (3)

  • Correlation between central laboratory and POCT results.

    2-4 hours

  • Influence of transport type.

    2-4 hours

  • Influence of daytime and weekday on results availability.

    2-4 hours

Study Arms (2)

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

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

Interventions

POCT and central laboratory blood analysisDIAGNOSTIC_TEST

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

Delivery roomEmergency room

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age \> 18 years

You may not qualify if:

  • Missing written consent
  • Withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Study Officials

  • Kai Zacharowski, Prof. Dr.

    Department of Anesthesia, Intensive Care Medicine and Pain Therapy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 8, 2017

Study Start

October 26, 2017

Primary Completion

November 30, 2018

Study Completion

February 28, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)