NCT05286671

Brief Summary

Pilot study to evaluate the management of curative anticoagulant prescriptions pre- and postoperatively in elderly patients hospitalized for femoral neck fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Last Updated

April 26, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

February 18, 2022

Last Update Submit

April 19, 2022

Conditions

Keywords

older patientsanticoagulantfemoral neck fracturesclinical pharmacy service

Outcome Measures

Primary Outcomes (2)

  • Rate of compliance with the recommendations for direct oral anticoagulants (DOAC)..

    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).

    Rate of compliance with the french health authority (HAS) recommendations for VKA

    Day 0

Secondary Outcomes (5)

  • Number of pharmaceutical interventions

    Day 0

  • description of pharmaceutical interventions

    Day 0

  • Evaluation of the morbi-mortality

    Day 0

  • Description of the evolution of the plasma dosage of DOAC and the international normalized ratio (INR) and analysis of the operative delay

    Day 0

  • description of the population

    Day 0

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Hemorrhagic DisordersFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 18, 2022

Study Start

February 1, 2022

Primary Completion

March 11, 2022

Study Completion

March 11, 2022

Last Updated

April 26, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations