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

Anticoagulation With Direct Oral Anticoagulants Clinical Trial

— POCT-DOAC 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371070
• Other study ID #: .1 259/2013BO1
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: June 30, 2016
• Start date: December 2013
• Est. completion date: May 2016

Study information

• Verified date: February 2015
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anticoagulation With Direct Oral Anticoagulants

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Heart and Diabetes Center North Rhine-Westphalia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours	No
Secondary	Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels		24h	No
Secondary	Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay		24h	No