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

NCT ID: NCT06382584

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-01

Brief Summary

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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

Detailed Description

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Conditions

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Direct Oral Anticoagulants (DOACs) Femoral Fractures Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Anti XA

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

Femoral fracture surgery

Intervention Type PROCEDURE

Hip fracture surgery

Interventions

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Femoral fracture surgery

Hip fracture surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Cuvillon

Role: PRINCIPAL_INVESTIGATOR

CHU NIMES

Locations

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CHU de NIMES

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 41052671 (View on PubMed)

Other Identifiers

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IRB_23.09.01

Identifier Type: -

Identifier Source: org_study_id

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