NCT01613443

Brief Summary

Concentration determinations of anticoagulants require plasma instead of whole blood, and results are not immediately available to clinicians. Monitoring anticoagulants concentration along with bedside methods may provide an alternative guide for administration of the NOAC. The purpose of this investigation is to compare bedside coagulation assays in whole blood with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with therapeutic dosis of NOAC.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

June 5, 2012

Last Update Submit

March 11, 2024

Conditions

Effect of NOAC on POCT

Keywords

Dabigatran, Rivaroxaban, Point of Care-testing

Study Arms (4)

Control

Healthy volunteers without medication

Phenprocoumon

Patients receiving Marcumar having target INR 2-3

Dabigatran

Patients receiving therapeutic dosis of Pradaxa

Rivaroxaban

Patients receiving therapeutic dosis of Xarelto

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients indicated for NOAC-therapy

You may not qualify if:

  • Patients treated with dabigatran 2x150mg / d for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation are included.
  • Moreover, patients treated with rivaroxaban 20 mg / d for DVT prophylaxis and treatment of recurrent DVT or PE are included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mani H, Herth N, Kasper A, Wendt T, Schuettfort G, Weil Y, Pfeilschifter W, Linnemann B, Herrmann E, Lindhoff-Last E. Point-of-care coagulation testing for assessment of the pharmacodynamic anticoagulant effect of direct oral anticoagulant. Ther Drug Monit. 2014 Oct;36(5):624-31. doi: 10.1097/FTD.0000000000000064.

    PMID: 24577124RESULT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Lindhoff-Last

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

March 12, 2024

Record last verified: 2024-03