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

NCT02894450 | Completed

• 1 other identifier: RC14_0402
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; oral anticoagulant; bioassay; elderly subject

Outcome Measures

Primary Outcomes (1)

• bioassay direct oral anticoagulants

  Baseline

Interventions

blood test OTHER

bioassay xaban

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Pascal Chevalet, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 9, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 9, 2016

Record last verified: 2016-09