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Trial record 72 of 643 for:    test AND point-of-care

Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2 (POCT-DOAC 2)

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ClinicalTrials.gov Identifier: NCT02371070
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
Heart and Diabetes Center North Rhine-Westphalia
Information provided by (Responsible Party):
University Hospital Tuebingen

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.

Condition or disease
Anticoagulation With Direct Oral Anticoagulants

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2
Study Start Date : December 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort
Rivaroxaban
N=20
Apixaban
N=20
Dabigatran
N=20



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Whole blood samples and citrated plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371070


Sponsors and Collaborators
University Hospital Tuebingen
Heart and Diabetes Center North Rhine-Westphalia
Investigators
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Principal Investigator: Sven Poli, Dr. University Hospital Tuebingen