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

NCT02371070 | Completed

• 1 other identifier: .1 259/2013BO1
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anticoagulation With Direct Oral Anticoagulants

Outcome Measures

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

  24 hours

Secondary Outcomes (2)

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

  24h

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

  24h

Study Arms (3)

Rivaroxaban

N=20

Apixaban

N=20

Dabigatran

N=20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator

Related Publications (2)

• 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.

  PMID: 28775134 DERIVED

• 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.

  PMID: 28196509 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples and citrated plasma samples

Study Officials

• Sven Poli, Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 25, 2015
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2016
• Last Updated: July 1, 2016

Record last verified: 2015-02