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Completed

NCT Number: NCT06382584

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NIMES

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral fracture surgery

Procedure

Hip fracture surgery

Primary outcomes

  1. Hospital Mortality

    Time frame: Day 0 to Day 28

    hospital mortality within 28 days of the date of hospital admission for femoral head fracture

Secondary outcomes

  1. Duration of the surgery

    Time frame: During surgery

    Time required for surgery

  2. Transfusion

    Time frame: Day 0 to Day 28

    Need for a transfusion

  3. Postoperative comorbidities

    Time frame: Day 0 to Day 28

    postoperative comorbidities during surgery and until day 28

  4. Hospital stay

    Time frame: Day 0 to Day 28

    length of hospital stay

  5. Anti Xa assay

    Time frame: Day 0 to Day 28

    anti Xa assay during hospitalisation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: ANTI_XA AOD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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