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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 18, 2015
First Posted Date February 25, 2015
Last Update Posted Date July 1, 2016
Study Start Date December 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2015)
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
Original Primary Outcome Measures
 (submitted: February 24, 2015)
Effect/Correlation of DOAC on Hemochron Signature POCT result [ Time Frame: 24 hours ]
DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry
Change History
Current Secondary Outcome Measures
 (submitted: February 25, 2015)
  • Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels [ Time Frame: 24h ]
  • Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay [ Time Frame: 24h ]
Original Secondary Outcome Measures
 (submitted: February 24, 2015)
  • Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels [ Time Frame: 24h ]
  • Effect/Correlation of DOAC on PT/aPTT/anti-Xa activity/Hemoclot assay [ Time Frame: 24h ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2
Official Title Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood samples and citrated plasma samples
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.
Condition Anticoagulation With Direct Oral Anticoagulants
Intervention Not Provided
Study Groups/Cohorts
  • Rivaroxaban
    N=20
  • Apixaban
    N=20
  • Dabigatran
    N=20
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2015)
60
Original Actual Enrollment Same as current
Actual Study Completion Date May 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02371070
Other Study ID Numbers .1 259/2013BO1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital Tuebingen
Study Sponsor University Hospital Tuebingen
Collaborators Heart and Diabetes Center North Rhine-Westphalia
Investigators
Principal Investigator: Sven Poli, Dr. University Hospital Tuebingen
PRS Account University Hospital Tuebingen
Verification Date February 2015