Clinical Trials Directory

Trials / Completed

CompletedNCT06382584

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
Phase
Study type
Observational
Enrollment
610 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREFemoral fracture surgeryHip fracture surgery

Timeline

Start date
2022-01-01
Primary completion
2023-06-01
Completion
2023-06-01
First posted
2024-04-24
Last updated
2026-01-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06382584. Inclusion in this directory is not an endorsement.