Direct Oral Anticoagulants (DOACs)ANTI_XA AODNCT06382584
Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur
An observational study of Direct Oral Anticoagulants (DOACs) and Femoral Fractures, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Direct Oral Anticoagulants (DOACs), Femoral Fractures, Surgery
- What is being tested?
- Femoral fracture surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 610 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Femoral fracture surgery
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral fracture surgeryProcedure or surgery
Hip fracture surgery
| Study group | Role | What they receive |
|---|---|---|
| Anti XA | adults treated with direct oral factor Xa inhibitors undergoing Femoral head fracture surgery Receives: Procedure: Femoral fracture surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
hospital mortality within 28 days of the date of hospital admission for femoral head fracture
Measured: Day 0 to Day 28
Secondary outcomes (5)
Duration of the surgery
Time required for surgery
Measured: During surgery
Transfusion
Need for a transfusion
Measured: Day 0 to Day 28
Postoperative comorbidities
postoperative comorbidities during surgery and until day 28
Measured: Day 0 to Day 28
Hospital stay
length of hospital stay
Measured: Day 0 to Day 28
Anti Xa assay
anti Xa assay during hospitalisation
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Direct Oral Anticoagulants (DOACs)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Cuvillon, Principal investigator, CHU NIMES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382584
- Sponsor's protocol ID
- IRB_23.09.01
- Acronym
- ANTI_XA AOD
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41052671
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06382584
- Acronym / sponsor ID
- ANTI_XA AOD / IRB_23.09.01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti XA | – | Procedure: Femoral fracture surgeryadults treated with direct oral factor Xa inhibitors undergoing Femoral head fracture surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral fracture surgeryHip fracture surgery | Procedure or surgery | Anti XA |
Primary outcome
Hospital Mortality
Time frame: Day 0 to Day 28
hospital mortality within 28 days of the date of hospital admission for femoral head fracture
5 secondary outcomes
Duration of the surgery
Time frame: During surgery
Transfusion
Time frame: Day 0 to Day 28
Postoperative comorbidities
Time frame: Day 0 to Day 28
Hospital stay
Time frame: Day 0 to Day 28
Anti Xa assay
Time frame: Day 0 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Results publication: PubMed 41052671Gricourt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Cuvillon principal investigator
CHU NIMES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Direct Oral Anticoagulants (DOACs) and Femoral Fractures, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Mortality (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06382584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.