DOAC Eligible SubjectsNCT02798328
Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System
An observational study of DOAC Eligible Subjects, run by Haemonetics Corporation at 4 sites in United States.
Trial summary
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- DOAC Eligible Subjects
- What is being tested?
- TEG6s DOAC Cartridge
- Type of treatment
- Medical device
- How many people
- 385 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: DOAC Eligible Subjects
Who may be able to join
- ≥ 18 years old
- DOAC administered for a minimum of 7 days
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
Inova Health Care Services
Falls Church, Virginia, 22042
Memorial Hospital South Bend
South Bend, Indiana, 46601
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303
About this study
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.
- Conditions
- DOAC Eligible Subjects
- Being tested
- TEG6s DOAC Cartridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEG6s DOAC CartridgeDevice
Testing subjects for presence of DOAC
| Study group | Role | What they receive |
|---|---|---|
| Reference Range | Healthy Subjects Receives: Device: TEG6s DOAC Cartridge | |
| DOAC Pivotal | DOAC Eligible Subjects Receives: Device: TEG6s DOAC Cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence / Absence of DOAC Drug
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DOAC Eligible SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798328
- Sponsor's protocol ID
- TP-CLN-100394
- Status last verified
- Feb 2020
- First submitted
- 2 Jun 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System
- ClinicalTrials.gov ID
- NCT02798328
- Acronym / sponsor ID
- TP-CLN-100394
- Conditions
- DOAC Eligible Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Range | – | Device: TEG6s DOAC CartridgeHealthy Subjects |
| DOAC Pivotal | – | Device: TEG6s DOAC CartridgeDOAC Eligible Subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- DOAC Eligible Subjects
Key inclusion criteria (2 listed)
- ≥ 18 years old
- DOAC administered for a minimum of 7 days
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEG6s DOAC CartridgeTesting subjects for presence of DOAC | Device | DOAC Pivotal, Reference Range |
Primary outcome
Presence / Absence of DOAC Drug
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DOAC Eligible Subjects, run by Haemonetics Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence / Absence of DOAC Drug (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.