Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System
1 other identifier
observational
385
1 country
4
Brief Summary
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFebruary 11, 2020
February 1, 2020
1.1 years
June 2, 2016
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Presence / Absence of DOAC Drug
1 week
Study Arms (2)
Reference Range
Healthy Subjects
DOAC Pivotal
DOAC Eligible Subjects
Interventions
Eligibility Criteria
DOAC Eligible Subjects
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memorial Hospital South Bend
South Bend, Indiana, 46601, United States
Essentia Institute of Rural Health
Duluth, Minnesota, 55805, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303, United States
Inova Health Care Services
Falls Church, Virginia, 22042, United States
Biospecimen
Whole blood sample
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2016
First Posted
June 14, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
February 11, 2020
Record last verified: 2020-02