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

Haemonetics

Status: Completed

Conditions: DOAC Eligible Subjects

Treatments: Device: TEG6s DOAC Cartridge

Study type: Observational

Funder types: Industry

Identifiers

NCT02798328

TP-CLN-100394

Details and patient eligibility

About

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

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

385 participants in 2 patient groups

Reference Range

Description:

Healthy Subjects

Treatment:

Device: TEG6s DOAC Cartridge

DOAC Pivotal

Description:

DOAC Eligible Subjects

Treatment:

Device: TEG6s DOAC Cartridge