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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 2016
End Date:June 2018
Contact:Hardean E Achneck, MD
Email:hardean.achneck@haemonetics.com
Phone:781-348-7393

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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.


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
We found this trial at
4
sites
Falls Church, Virginia 22042
Principal Investigator: Paul Gurbel, MD
Phone: 703-776-3855
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Duluth, Minnesota 55805
Principal Investigator: Ramin Artang, MD
Phone: 218-786-4869
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615 N Michigan St
South Bend, Indiana 46601
(574) 647-1000
Principal Investigator: Mark Walsh, MD
Phone: 574-647-7459
Memorial Hospital of South Bend Memorial Hospital of South Bend is a community-owned, not-for-profit corporation...
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South Bend, IN
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Spartanburg, South Carolina 29303
Principal Investigator: Brian Thurston, MD
Phone: 864-560-1046
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