Specific PoC Testing of Coagulation in Patients Treated With DOAC 1 (SPOCT-DOAC 1)

December 14, 2020 updated by: Dr. Sven Poli, University Hospital Tuebingen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
apixaban initiation
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Names:
  • Cascade Abrazo with ENOX and ENOX LR test cards
apixaban on-treatment
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Names:
  • Cascade Abrazo with ENOX and ENOX LR test cards
dabigatran initiation
N=20
Other: ecarin clotting time point-of-care testing (ECT-POCT)
Other Names:
  • Cascade Abrazo with DTM test cards
dabigatran on-treatment
N=20
Other: ecarin clotting time point-of-care testing (ECT-POCT)
Other Names:
  • Cascade Abrazo with DTM test cards
rivaroxaban initiation
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Names:
  • Cascade Abrazo with ENOX and ENOX LR test cards
rivaroxaban on-treatment
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Names:
  • Cascade Abrazo with ENOX and ENOX LR test cards
edoxaban initiation
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Names:
  • Cascade Abrazo with ENOX and ENOX LR test cards
edoxaban on-treatment
N=20
Other: anti-Xa activity point-of-care testing (aXa-POCT)
Other Names:
  • Cascade Abrazo with ENOX and ENOX LR test cards

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels
Time Frame: 24 hours
24 hours
Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay
Time Frame: 24 hours
24 hours
Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay
Time Frame: 24 hours
24 hours
Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay
Time Frame: 24 hours
24 hours
Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay
Time Frame: 24 hours
24 hours
Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay
Time Frame: 24 hours
24 hours
Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay
Time Frame: 24 hours
24 hours
Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay
Time Frame: 24 hours
24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay
Time Frame: 24 hours
24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay
Time Frame: 24 hours
24 hours
Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay
Time Frame: 24 hours
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
24 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Tuebingen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heart and Diabetes Center North Rhine-Westphalia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 270/2015BO1

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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