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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06382584
Acronym
ANTI_XA AOD
Enrollment
610
Registered
2024-04-24
Start date
2022-01-01
Completion date
2023-06-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Direct Oral Anticoagulants (DOACs), Femoral Fractures, Surgery

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

Interventions

PROCEDUREFemoral fracture surgery

Hip fracture surgery

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital MortalityDay 0 to Day 28hospital mortality within 28 days of the date of hospital admission for femoral head fracture

Secondary

MeasureTime frameDescription
Duration of the surgeryDuring surgeryTime required for surgery
TransfusionDay 0 to Day 28Need for a transfusion
Postoperative comorbiditiesDay 0 to Day 28postoperative comorbidities during surgery and until day 28
Hospital stayDay 0 to Day 28length of hospital stay
Anti Xa assayDay 0 to Day 28anti Xa assay during hospitalisation

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPhilippe Cuvillon

CHU NIMES

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026