Impact of Treatment With Oral Anticoagulants of Patients... | NCT06382584

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

NCT06382584

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jan 23, 2026Actual

Enrollment

610Actual

Phase

Not provided

Conditions

Direct Oral Anticoagulants (DOACs)
Femoral Fractures
Surgery

Interventions

Femoral fracture surgery

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jun 1, 2023Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Dec 6, 2023

First Submission Date that Met QC Criteria

Apr 23, 2024

First Posted Date

Apr 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

610Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anti XA		adults treated with direct oral factor Xa inhibitors undergoing Femoral head fracture surgery	Procedure: Femoral fracture surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Femoral fracture surgery	Procedure	Hip fracture surgery	Anti XA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital Mortality	hospital mortality within 28 days of the date of hospital admission for femoral head fracture	Day 0 to Day 28

Secondary Outcomes

Measure	Description	Time Frame
Duration of the surgery	Time required for surgery	During surgery
Transfusion	Need for a transfusion	Day 0 to Day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly Patients treated with direct oral factor Xa inhibitors requiring osteosynthesis surgery for isolated fracture of the upper end of the femur recorded in Nimes University Hospital database between January 1, 2022 and June 1, 2023.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Cuvillon	CHU NIMES	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de NIMES		Nîmes		30029	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41052671	Result	Gricourt Y, Perin M, Basseres N, Geronimi L, Lefrant JY, Mezzarobba M, Chea M, Gris JC, Cuvillon P. Impact of direct oral anticoagulant treatment on management and outcomes of patients with hip fractures by monitoring assays. A population-based study of a cohort from the Geriatric Perioperative Unit. Anaesth Crit Care Pain Med. 2026 Jan;45(1):101616. doi: 10.1016/j.accpm.2025.101616. Epub 2025 Oct 4.

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries