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

February 10, 2020 updated by: Haemonetics Corporation
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital South Bend
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Institute of Rural Health
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Healthcare System
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Health Care Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

DOAC Eligible Subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Reference Range
Healthy Subjects
Device: TEG6s DOAC Cartridge
Testing subjects for presence of DOAC
DOAC Pivotal
DOAC Eligible Subjects
Device: TEG6s DOAC Cartridge
Testing subjects for presence of DOAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence / Absence of DOAC Drug
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haemonetics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TP-CLN-100394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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