Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur

NCT06382584 | Completed

• 1 other identifier: IRB_23.09.01
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Direct Oral Anticoagulants (DOACs); Femoral Fractures; Surgery

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality

  hospital mortality within 28 days of the date of hospital admission for femoral head fracture

  Day 0 to Day 28

Secondary Outcomes (5)

• Duration of the surgery

  During surgery

• Transfusion

  Day 0 to Day 28

• Postoperative comorbidities

  Day 0 to Day 28

• Hospital stay

  Day 0 to Day 28

• Anti Xa assay

  Day 0 to Day 28

Study Arms (1)

Anti XA

adults treated with direct oral factor Xa inhibitors undergoing Femoral head fracture surgery

Procedure: Femoral fracture surgery

Interventions

Femoral fracture surgery PROCEDURE

Hip fracture surgery

Anti XA

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 41052671 RESULT

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Philippe Cuvillon

  CHU NIMES

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: April 24, 2024
• Study Start: January 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)