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OpenTrials
Completed

NCT Number: NCT02798328

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Hospital South Bend, South Bend, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

TEG6s DOAC Cartridge

Device

Testing subjects for presence of DOAC

Primary outcomes

  1. Presence / Absence of DOAC Drug

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Haemonetics Corporation

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2016
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.