Femur FractureSTOP-NACONCT06220422
Assessment of a Procedure for Managing Oral Anticoagulants (NACO) in the Management of Fractures
An observational study of Femur Fracture, run by Hôpital NOVO at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that by allowing patients with an anticoagulant level less than 100 ng/ml to have their fracture managed surgically, will reduce the delay in surgery and therefore the complications associated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Standard Department procedure for managing direct-acting oral anticoagulants and New Department procedure for managing direct-acting oral anticoagulants
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2024to 10 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on new anticoagulants undergoing surgery for fracture of the upper end of the femur between 2018 and 2023
Who may be able to join
- Patients on NACO undergoing surgery for fracture of the upper end of the femur,
- 18 years and over,
- Informed patients who did not object.
Who cannot join
- Patients under court protection,
- Patients under guardianship/curators .
Trial locations and contacts
1 site in 1 country.
France1 site
Anaesthetics department - Hôpital NOVO - Pontoise Site
Pontoise, 95300
About this study
Official title: Assessment the Benefit of a Service Procedure Management of NACO in the Treatment of Fractures of the Upper Extremity of the Femur
The purpose of this study is to demonstrate that by allowing patients with an anticoagulant level less than 100 ng/ml to have their fracture managed surgically, will reduce the delay in surgery and therefore the complications associated. It will also demonstrate that there are no more complications with this new management than from remaining with a bleeding fracture.
Read the detailed description
Fracture of the upper extremity of the femur are constantly on the increase and represent a public health issue in a population with increasing life expectancy. In the majority of cases, this fracture requires rapid surgical treatment, ideally within 48 hours, before complications, associated with the supine position, appear. A prolonged surgical delay is responsible for multiple complications and increase mortality in a potentially comorbid and fragile population.
Oral anticoagulants (NACOs) are now widely used in general population for cardiovascular diseases, such as non-valvular atrial fibrillation or thrombo-embolic events. Their activity and circulation rate are assessed by an Anti-Xa assay. The current recommendation for scheduled surgery is an assay with an anti-Xa activity of less than 50 ng/mL.
The acquisition of this assay and the wait for a decrease in anti-Xa activity are currently a factor of lengthening the surgical delay leading to proposal a new dosage. By offering the possibility of surgical management with an anti-Xa activity of less than 100 ng/ml, the purpose is to demonstrate a reduction in surgical delay (less than 48 hours) and associated complications. One of the secondary purposes is also to demonstrate that there are no more intra and post-operative complications with this new protocol.
- Conditions
- Femur Fracture
- Being tested
- Standard Department procedure for managing direct-acting oral anticoagulants, New Department procedure for managing direct-acting oral anticoagulants
- Keywords
- NACO, Fracture, Upper end of the femur, Department new procedure
- Medical subject headings
- Femoral Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Department procedure for managing direct-acting oral anticoagulantsProcedure or surgery
Standard Department procedure for managing direct-acting oral anticoagulants (NACO < 50 ng/mL) in the management of fractures before September 2021
New Department procedure for managing direct-acting oral anticoagulantsProcedure or surgery
New Department procedure for managing direct-acting oral anticoagulants (NACO < 100 ng/mL) in the management of fractures after September 2021
| Study group | Role | What they receive |
|---|---|---|
| Standard Department procedure for managing direct-acting oral anticoagulants | Standard Department procedure for managing direct-acting oral anticoagulants (NACO < 50 ng/mL) in the management of fractures before September 2021 Receives: Procedure: Standard Department procedure for managing direct-acting oral anticoagulants | |
| New Department procedure for managing direct-acting oral anticoagulants | Intervention Description New Department procedure for managing direct-acting oral anticoagulants (NACO < 100 ng/mL) in the management of fractures after September 2021 Receives: Procedure: New Department procedure for managing direct-acting oral anticoagulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highlighting of a reduction in the time to surgical management of fracture of the upper end of the femur by adjusting the preoperative threshold for the dosage of of direct-acting oral anticoagulants
Comparison of time from hospital admission to surgery (in hours) between both groups
Measured: At the end of the study, an average of 1 month
Secondary outcomes (7)
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on estimated intraoperative blood loss
Comparison on the amount of blood lost (mL) between both groups
Measured: At the end of the study, an average of 1 month
Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on transfusion requirement
The impact on transfusion requirements between both groups is evaluate on the following items :
- Packed red blood cells,
- Fresh frozen plasma,
- Unit concentrate of platelets,
- 4-factor prothrombin complex concentrate.
Measured: At the end of the study, an average of 1 month
Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital morbidity
The impact on Hospital morbidity between both groups is evaluate on the following complications :
- Infectious complications (surgical site infection, nosocomial infections: urinary, pneumonia, others),
- Thromboembolic complications (pulmonary embolism, deep vein thrombosis),
- Cardiovascular complications (decompensation of heart failure, Acute pulmonary oedema, ACS),
- Post-operative haemorrhagic complications (surgical site haematoma requiring treatment),
- 30-day readmission
Measured: At the end of the study, an average of 1 month
Measure the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital mortality
Comparison on the number of deaths in each group.
Measured: At the end of the study, an average of 1 month
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the complications affecting surgical management
The impact on the factors affecting surgical management between both groups is evaluate on the following item :
- Complications of the supine position (bedsores, etc.) and those related to the field (confusion, physical restraint indwelling catheter, stay in intensive care, resumption walking /chair, delay in returning home, Follow-up care and rehabilitation (SSR), geriatric assessment, nutritional management)
Measured: At the end of the study, an average of 1 month
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the degree of dependence due to surgical management
The impact on the factors affecting surgical management between both groups is evaluate on the following item :
- Degree of dependence according to the Katz evaluation scale, The KATZ scale is used to determine the degree of dependency of patients. It consists of a questionnaire assessing their abilities in 6 areas of daily life. For each area, the response varies between 4 scores ranging from no assistance to the need for total assistance.
Measured: At the end of the study, an average of 1 month
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the factors affecting surgical management
The impact on the factors affecting surgical management between both groups is evaluate on the following item :
- Day of admission to care (weekend/holiday/on-call day)
Measured: At the end of the study, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start26 Feb 2024
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- 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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Amélie TOUSSAINT, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220422
- Sponsor's protocol ID
- CHRD0123
- Acronym
- STOP-NACO
- Status last verified
- Jun 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Benefit of a Service Procedure Management of NACO in the Treatment of Fractures of the Upper Extremity of the Femur
- ClinicalTrials.gov ID
- NCT06220422
- Acronym / sponsor ID
- STOP-NACO / CHRD0123
- Conditions
- Femur Fracture
- Keywords
- NACO, Fracture, Upper end of the femur, Department new procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 24 Jan 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.
The purpose of this study is to demonstrate that by allowing patients with an anticoagulant level less than 100 ng/ml to have their fracture managed surgically, will reduce the delay in surgery and therefore the complications associated. It will also demonstrate that there are no more complications with this new management than from remaining with a bleeding fracture.
Detailed description
Fracture of the upper extremity of the femur are constantly on the increase and represent a public health issue in a population with increasing life expectancy. In the majority of cases, this fracture requires rapid surgical treatment, ideally within 48 hours, before complications, associated with the supine position, appear. A prolonged surgical delay is responsible for multiple complications and increase mortality in a potentially comorbid and fragile population.
Oral anticoagulants (NACOs) are now widely used in general population for cardiovascular diseases, such as non-valvular atrial fibrillation or thrombo-embolic events. Their activity and circulation rate are assessed by an Anti-Xa assay. The current recommendation for scheduled surgery is an assay with an anti-Xa activity of less than 50 ng/mL.
The acquisition of this assay and the wait for a decrease in anti-Xa activity are currently a factor of lengthening the surgical delay leading to proposal a new dosage. By offering the possibility of surgical management with an anti-Xa activity of less than 100 ng/ml, the purpose is to demonstrate a reduction in surgical delay (less than 48 hours) and associated complications. One of the secondary purposes is also to demonstrate that there are no more intra and post-operative complications with this new protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Department procedure for managing direct-acting oral anticoagulants | – | Procedure: Standard Department procedure for managing direct-acting oral anticoagulantsStandard Department procedure for managing direct-acting oral anticoagulants (NACO < 50 ng/mL) in the management of fractures before September 2021 |
| New Department procedure for managing direct-acting oral anticoagulants | – | Procedure: New Department procedure for managing direct-acting oral anticoagulantsIntervention Description New Department procedure for managing direct-acting oral anticoagulants (NACO < 100 ng/mL) in the management of fractures after September 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on new anticoagulants undergoing surgery for fracture of the upper end of the femur between 2018 and 2023
Key inclusion criteria (3 listed)
- Patients on NACO undergoing surgery for fracture of the upper end of the femur,
- 18 years and over,
- Informed patients who did not object.
Key exclusion criteria (2 listed)
- Patients under court protection,
- Patients under guardianship/curators .
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 |
|---|---|---|
| Standard Department procedure for managing direct-acting oral anticoagulantsStandard Department procedure for managing direct-acting oral anticoagulants (NACO < 50 ng/mL) in the management of fractures before September 2021 | Procedure or surgery | Standard Department procedure for managing direct-acting oral anticoagulants |
| New Department procedure for managing direct-acting oral anticoagulantsNew Department procedure for managing direct-acting oral anticoagulants (NACO < 100 ng/mL) in the management of fractures after September 2021 | Procedure or surgery | New Department procedure for managing direct-acting oral anticoagulants |
Primary outcome
Highlighting of a reduction in the time to surgical management of fracture of the upper end of the femur by adjusting the preoperative threshold for the dosage of of direct-acting oral anticoagulants
Time frame: At the end of the study, an average of 1 month
Comparison of time from hospital admission to surgery (in hours) between both groups
7 secondary outcomes
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on estimated intraoperative blood loss
Time frame: At the end of the study, an average of 1 month
Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on transfusion requirement
Time frame: At the end of the study, an average of 1 month
Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital morbidity
Time frame: At the end of the study, an average of 1 month
Measure the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital mortality
Time frame: At the end of the study, an average of 1 month
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the complications affecting surgical management
Time frame: At the end of the study, an average of 1 month
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the degree of dependence due to surgical management
Time frame: At the end of the study, an average of 1 month
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the factors affecting surgical management
Time frame: At the end of the study, an average of 1 month
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 12 Jun 2024.
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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.
Dr Amélie TOUSSAINT principal investigator
Hôpital NOVO
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 Femur Fracture, run by Hôpital NOVO 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 3 inclusion and 2 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 12 Jun 2024. 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?
Highlighting of a reduction in the time to surgical management of fracture of the upper end of the femur by adjusting the preoperative threshold for the dosage of of direct-acting oral anticoagulants (time frame: At the end of the study, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2024.