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

Surgery Clinical Trial

— ANTI_XA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06382584
• Other study ID #: IRB_23.09.01
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Surgery

Intervention

Procedure:
• Femoral fracture surgery
Hip fracture surgery

Locations

Country	Name	City	State
France	CHU de NIMES	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality	hospital mortality within 28 days of the date of hospital admission for femoral head fracture	Day 0 to Day 28
Secondary	Duration of the surgery	Time required for surgery	During surgery
Secondary	Transfusion	Need for a transfusion	Day 0 to Day 28
Secondary	Postoperative comorbidities	postoperative comorbidities during surgery and until day 28	Day 0 to Day 28
Secondary	Hospital stay	length of hospital stay	Day 0 to Day 28
Secondary	Anti Xa assay	anti Xa assay during hospitalisation	Day 0 to Day 28