Evaluation of Perioperative Management of Curative Anticoagulants in the Geriatric Perioperative Unit in Patient Hospitalized for Femoral Neck Fracture. (ANTICOGER)

April 19, 2022 updated by: Centre Hospitalier Universitaire de Nīmes
Pilot study to evaluate the management of curative anticoagulant prescriptions pre- and postoperatively in elderly patients hospitalized for femoral neck fracture.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

  • France
      • Nimes, France, 30029
        • CHU Nimes

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

Non-Probability Sample

Study Population

All patients aged 75 years and older, hospitalized in the geriatric perioperative unit from November 18, 2019 to June 30, 2021, for a hip fracture and with curative anticoagulant therapy prescription at entry.

Description

Inclusion Criteria:

  • Patient 75 years or older
  • Hospitalized in the geriatric perioperative unit for a femoral neck fracture between 18/11/2019 and 30/06/2021
  • Treated with a curative anticoagulant at entry
  • Patient enrolled in or receiving a social security plan

Exclusion Criteria:

  • Orthopedic patient housed in the geriatric perioperative unit
  • Patient who objected to the use of their data

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of compliance with the recommendations for direct oral anticoagulants (DOAC)..
Time Frame: Day 0
Rate of compliance with the french working group on perioperative haemostasis (GIHP) recommendations for DOACrecommendations for DOA.
Day 0
Rate of compliance with the recommendations for vitamin K antagonists (VKA).
Time Frame: Day 0
Rate of compliance with the french health authority (HAS) recommendations for VKA
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pharmaceutical interventions
Time Frame: Day 0
Number of pharmaceutical interventions regarding anticoagulant prescriptions
Day 0
description of pharmaceutical interventions
Time Frame: Day 0
description of pharmaceutical interventions
Day 0
Evaluation of the morbi-mortality
Time Frame: Day 0
Mortality, re-hospitalizations at 30 days, characterization of bleeding complications, characterization of thrombotic complications
Day 0
Description of the evolution of the plasma dosage of DOAC and the international normalized ratio (INR) and analysis of the operative delay
Time Frame: Day 0
Value of preoperative DOAC plasma dosage, value of INR dosage pre- and post-op, analysis of the operative delay
Day 0
description of the population
Time Frame: Day 0
age, weight, height, body mass index, comorbidities
Day 0

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

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)

February 1, 2022

Primary Completion (Actual)

March 11, 2022

Study Completion (Actual)

March 11, 2022

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2022/CC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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