- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02371070
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2 (POCT-DOAC 2)
June 30, 2016 updated by: University Hospital Tuebingen
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
60
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
No
Genders Eligible for Study
All
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.
Description
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:
- 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
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 |
---|
Rivaroxaban
N=20
|
Apixaban
N=20
|
Dabigatran
N=20
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect/Correlation of direct oral anticoagulants (DOAC) on Hemochron Signature point-of-care testing (POCT) result
Time Frame: 24 hours
|
DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay
Time Frame: 24h
|
24h
|
Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels
Time Frame: 24h
|
24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sven Poli, Dr., University Hospital Tuebingen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
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
December 1, 2013
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
February 18, 2015
First Submitted That Met QC Criteria
February 24, 2015
First Posted (Estimate)
February 25, 2015
Study Record Updates
Last Update Posted (Estimate)
July 1, 2016
Last Update Submitted That Met QC Criteria
June 30, 2016
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- .1 259/2013BO1
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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