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Specific PoC Testing of Coagulation in Patients Treated With DOAC 1 (SPOCT-DOAC 1)

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ClinicalTrials.gov Identifier: NCT02825394
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Heart and Diabetes Center North Rhine-Westphalia
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Tuebingen

Brief Summary:
The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.

Condition or disease Intervention/treatment
Anticoagulation With NOAC Other: anti-Xa activity point-of-care testing (aXa-POCT) Other: ecarin clotting time point-of-care testing (ECT-POCT)

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1
Study Start Date : September 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
apixaban initiation
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Name: Cascade Abrazo with ENOX and ENOX LR test cards

apixaban on-treatment
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Name: Cascade Abrazo with ENOX and ENOX LR test cards

dabigatran initiation
N=20
Other: ecarin clotting time point-of-care testing (ECT-POCT)
Other Name: Cascade Abrazo with DTM test cards

dabigatran on-treatment
N=20
Other: ecarin clotting time point-of-care testing (ECT-POCT)
Other Name: Cascade Abrazo with DTM test cards

rivaroxaban initiation
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Name: Cascade Abrazo with ENOX and ENOX LR test cards

rivaroxaban on-treatment
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Name: Cascade Abrazo with ENOX and ENOX LR test cards

edoxaban initiation
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Name: Cascade Abrazo with ENOX and ENOX LR test cards

edoxaban on-treatment
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Name: Cascade Abrazo with ENOX and ENOX LR test cards




Primary Outcome Measures :
  1. Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo 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 (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels [ Time Frame: 24 hours ]
  2. Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay [ Time Frame: 24 hours ]
  3. Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay [ Time Frame: 24 hours ]
  4. Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay [ Time Frame: 24 hours ]
  5. Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay [ Time Frame: 24 hours ]
  6. Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay [ Time Frame: 24 hours ]
  7. Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay [ Time Frame: 24 hours ]
  8. Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay [ Time Frame: 24 hours ]
  9. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay [ Time Frame: 24 hours ]
  10. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay [ Time Frame: 24 hours ]
  11. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay [ Time Frame: 24 hours ]
  12. Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay [ Time Frame: 24 hours ]

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


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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

Part A: patients, who are newly started on oral anticoagulation with apixaban, dabigatran, edoxaban or rivaroxaban for secondary prevention of thromboembolic events.

Part B: patients, on-treatment with apixaban, dabigatran, edoxaban or rivaroxaban.

Criteria

Inclusion Criteria:

  • Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban
  • Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban
  • Age ≥ 18 years
  • Written informed consent by patient

Exclusion Criteria:

  • Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation
  • Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation
  • Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation
  • Part A only: abnormal routine coagulation test values at baseline (defined by INR > 1.2, Quick < 70% or aPTT > 40 sec)
  • 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): NCT02825394


Contacts
Contact: Sven Poli, MD MSc +497071290 ext 68300 sven.poli@uni-tuebingen.de
Contact: Florian Härtig, MD +497071290 ext 80417 florian.haertig@uni-tuebingen.de

Locations
Germany
University Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Sven Poli, MD MSc    +497071290 ext 68300    sven.poli@uni-tuebingen.de   
Contact: Florian Härtig, MD    +497071290 ext 80417    florian.haertig@uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Heart and Diabetes Center North Rhine-Westphalia

Responsible Party: Dr. Sven Poli, MD MSc, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02825394     History of Changes
Other Study ID Numbers: 270/2015BO1
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Rivaroxaban
Apixaban
Edoxaban
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants