Clinical trial NCT06382584: Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Direct Oral Anticoagulants (DOACs)
Femoral Fractures
Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 610
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Hospital Mortality
timeFrame: Day 0 to Day 28
Secondary outcomes:
measure: Duration of the surgery
timeFrame: During surgery
measure: Transfusion
timeFrame: Day 0 to Day 28
measure: Postoperative comorbidities
timeFrame: Day 0 to Day 28
measure: Hospital stay
timeFrame: Day 0 to Day 28
measure: Anti Xa assay
timeFrame: Day 0 to Day 28
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
affiliation: CHU NIMES
name: Philippe Cuvillon
role: PRINCIPAL_INVESTIGATOR
References: