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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-09-30

Brief Summary

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

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Detailed Description

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Conditions

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DOAC Eligible Subjects

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Reference Range

Healthy Subjects

TEG6s DOAC Cartridge

Intervention Type DEVICE

Testing subjects for presence of DOAC

DOAC Pivotal

DOAC Eligible Subjects

TEG6s DOAC Cartridge

Intervention Type DEVICE

Testing subjects for presence of DOAC

Interventions

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TEG6s DOAC Cartridge

Testing subjects for presence of DOAC

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes