Anticoagulation With NOACSPOCT-DOAC 1NCT02825394
Specific PoC Testing of Coagulation in Patients Treated With DOAC 1
An observational study of Anticoagulation With NOAC, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation With NOAC
- What is being tested?
- anti-Xa activity point-of-care testing (aXa-POCT) and ecarin clotting time point-of-care testing (ECT-POCT)
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 13 Oct 2016to Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Part A: patients, who are newly started on oral anticoagulation with apixaban, dabigatran, edoxaban or rivaroxaban for secondary prevention of thromboembolic events. Part B: patients, on-treatment with apixaban, dabigatran, edoxaban or rivaroxaban.
Who may be able to join
- Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban
- Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban
- Age ≥ 18 years
- Written informed consent by patient
Who cannot join
- Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation
- Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation
- Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation
- Part A only: abnormal routine coagulation test values at baseline (defined by INR > 1.2, Quick < 70% or aPTT > 40 sec)
- History of coagulopathy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Sven Poli, MD MSc, +497071290 ext. 68300, sven.poli@uni-tuebingen.de
Florian Härtig, MD, +497071290 ext. 80417, florian.haertig@uni-tuebingen.de
About this study
Official title: Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1
The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.
- Conditions
- Anticoagulation With NOAC
- Being tested
- anti-Xa activity point-of-care testing (aXa-POCT), ecarin clotting time point-of-care testing (ECT-POCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-Xa activity point-of-care testing (aXa-POCT)Other
Also called Cascade Abrazo with ENOX and ENOX LR test cards
ecarin clotting time point-of-care testing (ECT-POCT)Other
Also called Cascade Abrazo with DTM test cards
| Study group | Role | What they receive |
|---|---|---|
| apixaban initiation | N=20 Receives: Other: anti-Xa activity point-of-care testing (aXa-POCT) | |
| apixaban on-treatment | N=20 Receives: Other: anti-Xa activity point-of-care testing (aXa-POCT) | |
| dabigatran initiation | N=20 Receives: Other: ecarin clotting time point-of-care testing (ECT-POCT) | |
| dabigatran on-treatment | N=20 Receives: Other: ecarin clotting time point-of-care testing (ECT-POCT) | |
| rivaroxaban initiation | N=20 Receives: Other: anti-Xa activity point-of-care testing (aXa-POCT) | |
| rivaroxaban on-treatment | N=20 Receives: Other: anti-Xa activity point-of-care testing (aXa-POCT) | |
| edoxaban initiation | N=20 Receives: Other: anti-Xa activity point-of-care testing (aXa-POCT) | |
| edoxaban on-treatment | N=20 Receives: Other: anti-Xa activity point-of-care testing (aXa-POCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result
DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry
Measured: 24 hours
Secondary outcomes (12)
Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels
Measured: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay
Measured: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay
Measured: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay
Measured: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay
Measured: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay
Measured: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay
Measured: 24 hours
Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay
Measured: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay
Measured: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay
Measured: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay
Measured: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start13 Oct 2016
- Primary completionMar 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anticoagulation With NOACStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia
- Responsible party
- Principal investigator, Dr. Sven Poli, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825394
- Sponsor's protocol ID
- 270/2015BO1
- Acronym
- SPOCT-DOAC 1
- Status last verified
- Dec 2020
- First submitted
- 28 Jun 2016
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hartig F, Birschmann I, Peter A, Horber S, Ebner M, Sonnleitner M, Spencer C, Bombach P, Stefanou MI, Tunnerhoff J, Mengel A, Kuhn J, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban. Neurol Res Pract. 2021 Mar 1;3(1):9. doi: 10.1186/s42466-021-00105-4.
PubMed 33641678Hartig F, Birschmann I, Peter A, Ebner M, Spencer C, Gramlich M, Richter H, Kuhn J, Lehmann R, Blumenstock G, Zuern CS, Ziemann U, Poli S. Specific Point-of-Care Testing of Coagulation in Patients Treated with Dabigatran. Thromb Haemost. 2021 Jun;121(6):782-791. doi: 10.1055/s-0040-1721775. Epub 2021 Jan 14.
PubMed 33469905
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1
- ClinicalTrials.gov ID
- NCT02825394
- Acronym / sponsor ID
- SPOCT-DOAC 1 / 270/2015BO1
- Conditions
- Anticoagulation With NOAC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 7 Jul 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.
The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| apixaban initiation | – | Other: anti-Xa activity point-of-care testing (aXa-POCT)N=20 |
| apixaban on-treatment | – | Other: anti-Xa activity point-of-care testing (aXa-POCT)N=20 |
| dabigatran initiation | – | Other: ecarin clotting time point-of-care testing (ECT-POCT)N=20 |
| dabigatran on-treatment | – | Other: ecarin clotting time point-of-care testing (ECT-POCT)N=20 |
| rivaroxaban initiation | – | Other: anti-Xa activity point-of-care testing (aXa-POCT)N=20 |
| rivaroxaban on-treatment | – | Other: anti-Xa activity point-of-care testing (aXa-POCT)N=20 |
| edoxaban initiation | – | Other: anti-Xa activity point-of-care testing (aXa-POCT)N=20 |
| edoxaban on-treatment | – | Other: anti-Xa activity point-of-care testing (aXa-POCT)N=20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Part A: patients, who are newly started on oral anticoagulation with apixaban, dabigatran, edoxaban or rivaroxaban for secondary prevention of thromboembolic events. Part B: patients, on-treatment with apixaban, dabigatran, edoxaban or rivaroxaban.
Key inclusion criteria (4 listed)
- Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban
- Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban
- Age ≥ 18 years
- Written informed consent by patient
Key exclusion criteria (5 listed)
- Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation
- Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation
- Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation
- Part A only: abnormal routine coagulation test values at baseline (defined by INR > 1.2, Quick < 70% or aPTT > 40 sec)
- History of coagulopathy
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 |
|---|---|---|
| anti-Xa activity point-of-care testing (aXa-POCT)Also: Cascade Abrazo with ENOX and ENOX LR test cards | Other | apixaban initiation, apixaban on-treatment, edoxaban initiation, edoxaban on-treatment, rivaroxaban initiation, rivaroxaban on-treatment |
| ecarin clotting time point-of-care testing (ECT-POCT)Also: Cascade Abrazo with DTM test cards | Other | dabigatran initiation, dabigatran on-treatment |
Primary outcome
Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result
Time frame: 24 hours
DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry
12 secondary outcomes
Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels
Time frame: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay
Time frame: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay
Time frame: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay
Time frame: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay
Time frame: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay
Time frame: 24 hours
Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay
Time frame: 24 hours
Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay
Time frame: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay
Time frame: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay
Time frame: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay
Time frame: 24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 33641678Hartig F, Birschmann I, Peter A, Horber S, Ebner M, Sonnleitner M, Spencer C, Bombach P, Stefanou MI, Tunnerhoff J, Mengel A, Kuhn J, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban. Neurol Res Pract. 2021 Mar 1;3(1):9. doi: 10.1186/s42466-021-00105-4.
- Derived from this study: PubMed 33469905Hartig F, Birschmann I, Peter A, Ebner M, Spencer C, Gramlich M, Richter H, Kuhn J, Lehmann R, Blumenstock G, Zuern CS, Ziemann U, Poli S. Specific Point-of-Care Testing of Coagulation in Patients Treated with Dabigatran. Thromb Haemost. 2021 Jun;121(6):782-791. doi: 10.1055/s-0040-1721775. Epub 2021 Jan 14.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation With NOAC, run by University Hospital Tuebingen at 1 site in Germany.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Poli, MD MSc (+497071290 ext. 68300, sven.poli@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825394, which also lists 2 linked publications.
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 16 Dec 2020.