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

Completed

• Conditions: DOAC Eligible Subjects
• Interventions: Device: TEG6s DOAC Cartridge

• Registration Number: NCT02798328
• Lead Sponsor: Haemonetics Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-14
• Study Start: 2016-08
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reference Range	TEG6s DOAC Cartridge	Healthy Subjects
DOAC Pivotal	TEG6s DOAC Cartridge	DOAC Eligible Subjects

Primary Outcome Measures

Name	Time	Method
Presence / Absence of DOAC Drug	1 week

Trial Locations

Locations (4)

Spartanburg Regional Healthcare System; 🇺🇸 Spartanburg, South Carolina, United States

Essentia Institute of Rural Health; 🇺🇸 Duluth, Minnesota, United States

Inova Health Care Services; 🇺🇸 Falls Church, Virginia, United States

Memorial Hospital South Bend; 🇺🇸 South Bend, Indiana, United States