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

Completed

• Conditions: Femoral Fractures; Surgery; Direct Oral Anticoagulants (DOACs)
• Interventions: Procedure: Femoral fracture surgery

• Registration Number: NCT06382584
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anti XA	Femoral fracture surgery	adults treated with direct oral factor Xa inhibitors undergoing Femoral head fracture surgery

Primary Outcome Measures

Name	Time	Method
Hospital Mortality	Day 0 to Day 28	hospital mortality within 28 days of the date of hospital admission for femoral head fracture

Secondary Outcome Measures

Name	Time	Method
Hospital stay	Day 0 to Day 28	length of hospital stay
Transfusion	Day 0 to Day 28	Need for a transfusion
Postoperative comorbidities	Day 0 to Day 28	postoperative comorbidities during surgery and until day 28
Duration of the surgery	During surgery	Time required for surgery
Anti Xa assay	Day 0 to Day 28	anti Xa assay during hospitalisation

Trial Locations

Locations (1)

CHU de NIMES; 🇫🇷 Nimes, France