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 |
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and
classify the presence of DOAC drugs in a subject.
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
Duluth, Minnesota 55805
Principal Investigator: Ramin Artang, MD
Phone: 218-786-4869
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Falls Church, Virginia 22042
Principal Investigator: Paul Gurbel, MD
Phone: 703-776-3855
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615 N Michigan St
South Bend, Indiana 46601
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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Spartanburg, South Carolina 29303
Principal Investigator: Brian Thurston, MD
Phone: 864-560-1046
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