DOAC Eligible Subjects
Conditions
Brief summary
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.
Interventions
DEVICETEG6s DOAC Cartridge
Testing subjects for presence of DOAC
Sponsors
Haemonetics Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 18 years old * DOAC administered for a minimum of 7 days
Exclusion criteria
* Genetic Bleeding disorders. Known or subsequently discovered inherited defects of coagulation (e.g. hemophilia or Von Willebrand disease) * Not known when last two DOAC doses were administered prior to blood draw * DOAC first administered (or resumed after temporary cessation) less than 7 days prior to blood draw * DOAC dosage outside of manufacturer's recommended range (e.g. study subject with renal impairment and supratherapeutic dose) * Heparin or LMWH administered within 7 days prior to blood draw * On any medications known to affect coagulation status and listed below * Bruising, wounds or scarring in the area of venipuncture List of medications known to affect coagulation status 1. Vitamin K Antagonists \[VKAs\] Warfarin Phenprocoumon Acenocoumarol Tecarfarin \[ATI-5923\] Phenindione Anisindione Elinogrel Vorapaxar Atopaxar 2. Heparin and Heparins Unfractionated Heparin \[UFH\] LMWH Fondaparinux Idraparinux Danaparoid 3. Vasopressin Analogues DDAVP 4. Direct Thrombin \[IIa\] Inhibitors Hirudin Lepirudin Bivalirudin Argatroban 5. Defibrinating Agents Ancrod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence / Absence of DOAC Drug | 1 week |
Countries
United States
Outcome results
None listed