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CompletedNCT02371070POCT-DOAC 2Updated Jul 1, 2016

Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2

An observational study in Anticoagulation With Direct Oral Anticoagulants, sponsored by University Hospital Tuebingen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-01.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study summary

The investigators study aims to test the correlation between the Hemochron Signature point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.

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Conditions studied

  • Anticoagulation With Direct Oral Anticoagulants
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In context

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.

Browse University Hospital Tuebingen studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
  • Age ≥ 18 years

Exclusion criteria

Exclusion Criteria:

  • Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation
  • Low-molecular weight heparin ≤ 24 hours
  • Unfractionated heparin ≤ 12 hours
  • Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) > 40sec.)
  • History of coagulopathy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Rivaroxaban

    N=20

  • Apixaban

    N=20

  • Dabigatran

    N=20

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What researchers measure

Primary outcomes

  1. Effect/Correlation of direct oral anticoagulants (DOAC) on Hemochron Signature point-of-care testing (POCT) result

    DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry

    Time frame: 24 hours

Secondary outcomes

  1. Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels

    Time frame: 24h

  2. Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay

    Time frame: 24h

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Ebner M, Birschmann I, Peter A, Hartig F, Spencer C, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Emergency Coagulation Assessment During Treatment With Direct Oral Anticoagulants: Limitations and Solutions. Stroke. 2017 Sep;48(9):2457-2463. doi: 10.1161/STROKEAHA.117.017981. Epub 2017 Aug 3. PubMed 28775134 ↗
  • Ebner M, Birschmann I, Peter A, Spencer C, Hartig F, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants. Crit Care. 2017 Feb 15;21(1):32. doi: 10.1186/s13054-017-1619-z. PubMed 28196509 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Nov 2015 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2015
First posted
Feb 25, 2015
Start
Dec 2013
Primary completionActual
Nov 2015
CompletionActual
May 2016
Last update
Jul 1, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02371070
Lead sponsor
University Hospital Tuebingen
Collaborators
Heart and Diabetes Center North Rhine-Westphalia
Responsible party
Sponsor
First posted
Feb 25, 2015
Start date
Dec 2013
Primary completion
Nov 2015
Completion
May 2016
Last update
Jul 1, 2016

Study contacts

Sven Poli, Dr.
principal investigator · University Hospital Tuebingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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