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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Direct Oral Anticoagulants (DOACs); Femoral Fractures; Surgery

Treatments: Procedure: Femoral fracture surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06382584

IRB_23.09.01

Details and patient eligibility

About

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

Enrollment: 610 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

610 participants in 1 patient group

Anti XA

Description:

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

Treatment:

Procedure: Femoral fracture surgery