Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay Higher Among Those Aged Over 75 Years (AOD-SA)

September 8, 2016 updated by: Nantes University Hospital

Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay (Xaban) Higher Among Those Aged Over 75 Years, as AOD for Atrial Fibrillation

The objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

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

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients over 75 years under anticoagulant treatment 'xaban' (dabigatran, rivaroxaban, Apixaban) for atrial fibrillation, hospital unscheduled manner in Medicine and Geriatric services Versatile Service Home Emergency CHU Nantes and where a hemostatic balance is expected to be offered the study.

The recruitment will be made on a 6-month period (November 2014 - April 2015). Bioassay 'xaban' will be made from the remainder of the tube removed for hemostasis tests provided in the usual care of patients.

Description

Inclusion Criteria:

  • Age ≥ 75 years
  • Entering SAU or MPG (Nantes University Hospital) as part of an unscheduled hospitalization for acute or subacute disease (About MPG, will be included patients admitted to the department within 48 hours of calling the doctor)
  • In xaban to entry (dabigatran, rivaroxaban, Apixaban) for non-valvular atrial fibrillation
  • In whom hemostasis tests will be prescribed as part of usual care
  • Patient has given its verbal agreement

Exclusion criteria

Patients with the following criteria may not be included:

  • Patients refusing to participate in the study
  • Patients under guardianship
  • Inability to obtain the date and time of the last dose of xaban

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bioassay direct oral anticoagulants
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Pascal Chevalet, Dr, Nantes University Hospital

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

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0402

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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