Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur (ANTI_XA AOD)

Impact of Treatment With Direct Oral Anticoagulants (Anti Xa) on the Management and Outcome of Patients With Fractures of the Upper End of the Femur: Retrospective Analysis of Nimes University Hospital Database

In 2023, oral anticoagulant treatments (anti Xa: apixaban , rivaroxaban, etc.) are tending to replace anti vitamin K treatments in many medical indications. Their prescription is increasing rapidly in the elderly.

In this context, the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugs.To avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. No consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). A plasma assay (threshold of <30 to 60 ng/mL) has been proposed without any real justification. This waiting period exposes the elderly to excess mortality. Reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk.

Before considering a prospective randomised study (early vs delayed surgery on AOD), we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023

Study Overview

• Status: Completed
• Conditions: Femoral Fractures; Surgery; Direct Oral Anticoagulants (DOACs)
• Intervention / Treatment: Procedure: Femoral fracture surgery

• Study Type: Observational
• Enrollment (Actual): 610

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Elderly Patients treated with direct oral factor Xa inhibitors requiring osteosynthesis surgery for isolated fracture of the upper end of the femur recorded in Nimes University Hospital database between January 1, 2022 and June 1, 2023.

Description

Inclusion Criteria:

• Adult patient > 65 years
• Emergency admission for isolated fracture of the upper end of the femur
• Requires osteosynthesis surgery
• Hospitalized in geriatric perioperative unit, chu Nimes (UPOG)
• On anti Xa therapy prior to hospitalisation

Exclusion Criteria:

• Patients under court order or not affiliated to a social security scheme
• Outpatient surgery
• Multiple fractures and/or other associated surgery
• Not admitted to UPOG
• No surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anti XA; adults treated with direct oral factor Xa inhibitors undergoing Femoral head fracture surgery	Procedure: Femoral fracture surgery; Hip fracture surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality	hospital mortality within 28 days of the date of hospital admission for femoral head fracture	Day 0 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the surgery	Time required for surgery	During surgery
Transfusion	Need for a transfusion	Day 0 to Day 28
Postoperative comorbidities	postoperative comorbidities during surgery and until day 28	Day 0 to Day 28
Hospital stay	length of hospital stay	Day 0 to Day 28
Anti Xa assay	anti Xa assay during hospitalisation	Day 0 to Day 28

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Philippe Cuvillon, CHU Nîmes

Publications and helpful links

General Publications

• Gricourt Y, Perin M, Basseres N, Geronimi L, Lefrant JY, Mezzarobba M, Chea M, Gris JC, Cuvillon P. Impact of direct oral anticoagulant treatment on management and outcomes of patients with hip fractures by monitoring assays. A population-based study of a cohort from the Geriatric Perioperative Unit. Anaesth Crit Care Pain Med. 2026 Jan;45(1):101616. doi: 10.1016/j.accpm.2025.101616. Epub 2025 Oct 4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: IRB_23.09.01

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