Specific PoC Testing of Coagulation in Patients Treated With DOAC 1

NCT02825394 | Unknown

• 1 other identifier: 270/2015BO1
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 anticoagulants (DOAC) in real-life patients.

Conditions

Anticoagulation With NOAC

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (12)

• Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels

  24 hours

• Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay

  24 hours

• Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay

  24 hours

• Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay

  24 hours

• Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay

  24 hours

Study Arms (8)

apixaban initiation

N=20

Other: anti-Xa activity point-of-care testing (aXa-POCT)

apixaban on-treatment

N=20

Other: anti-Xa activity point-of-care testing (aXa-POCT)

dabigatran initiation

N=20

Other: ecarin clotting time point-of-care testing (ECT-POCT)

dabigatran on-treatment

N=20

Other: ecarin clotting time point-of-care testing (ECT-POCT)

rivaroxaban initiation

N=20

Other: anti-Xa activity point-of-care testing (aXa-POCT)

rivaroxaban on-treatment

N=20

Other: anti-Xa activity point-of-care testing (aXa-POCT)

edoxaban initiation

N=20

Other: anti-Xa activity point-of-care testing (aXa-POCT)

edoxaban on-treatment

N=20

Other: anti-Xa activity point-of-care testing (aXa-POCT)

Interventions

anti-Xa activity point-of-care testing (aXa-POCT) OTHER

Also known as: Cascade Abrazo with ENOX and ENOX LR test cards

apixaban initiation; apixaban on-treatment; edoxaban initiation; edoxaban on-treatment; rivaroxaban initiation; rivaroxaban on-treatment

ecarin clotting time point-of-care testing (ECT-POCT) OTHER

Also known as: Cascade Abrazo with DTM test cards

dabigatran initiation; dabigatran on-treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 33641678 DERIVED

• Hartig 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.

  PMID: 33469905 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples, citrated blood samples and citrated plasma samples

Central Study Contacts

Sven Poli, MD MSc

CONTACT

+497071290; sven.poli@uni-tuebingen.de

Florian Härtig, MD

CONTACT

+497071290; florian.haertig@uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 7, 2016
• Study Start: October 13, 2016
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

DE (1)