Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System

Completed

Conditions studied: DOAC Eligible Subjects

In brief

Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.

Key facts

Study ID

NCT02798328

Run by

Haemonetics Corporation

People needed

385

Starts

2016-08-01

Expected to finish

2017-09-01

Last updated by the study team

2020-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 18 years old
• DOAC administered for a minimum of 7 days

You may not qualify if…

• 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
• Vitamin K Antagonists [VKAs] Warfarin Phenprocoumon Acenocoumarol Tecarfarin [ATI-5923] Phenindione Anisindione Elinogrel Vorapaxar Atopaxar
• Heparin and Heparins Unfractionated Heparin [UFH] LMWH Fondaparinux Idraparinux Danaparoid
• Vasopressin Analogues DDAVP
• Direct Thrombin [IIa] Inhibitors Hirudin Lepirudin Bivalirudin Argatroban
• Defibrinating Agents Ancrod

Where it is running

• Memorial Hospital South Bend — South Bend, Indiana, United States
• Essentia Institute of Rural Health — Duluth, Minnesota, United States
• Spartanburg Regional Healthcare System — Spartanburg, South Carolina, United States
• Inova Health Care Services — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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