Anticoagulants; Circulating, Hemorrhagic DisorderANTICOGERNCT05286671
Evaluation of Perioperative Management of Curative Anticoagulants in the Geriatric Perioperative Unit in Patient Hospitalized for Femoral Neck Fracture.
An observational study of Anticoagulants; Circulating, Hemorrhagic Disorder and Femoral Neck Fractures, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Pilot study to evaluate the management of curative anticoagulant prescriptions pre- and postoperatively in elderly patients hospitalized for femoral neck fracture. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Anticoagulants; Circulating, Hemorrhagic Disorder, Femoral Neck Fractures
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 11 Mar 2022
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients aged 75 years and older, hospitalized in the geriatric perioperative unit from November 18, 2019 to June 30, 2021, for a hip fracture and with curative anticoagulant therapy prescription at entry.
Who may be able to join
- Patient 75 years or older
- Hospitalized in the geriatric perioperative unit for a femoral neck fracture between 18/11/2019 and 30/06/2021
- Treated with a curative anticoagulant at entry
- Patient enrolled in or receiving a social security plan
Who cannot join
- Orthopedic patient housed in the geriatric perioperative unit
- Patient who objected to the use of their data
Trial locations and contacts
1 site in 1 country.
About this study
Pilot study to evaluate the management of curative anticoagulant prescriptions pre- and postoperatively in elderly patients hospitalized for femoral neck fracture.
- Keywords
- older patients, anticoagulant, femoral neck fractures, clinical pharmacy service
- Medical subject headings
- Hemorrhagic Disorders, Femoral Neck Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of compliance with the recommendations for direct oral anticoagulants (DOAC)..
Rate of compliance with the french working group on perioperative haemostasis (GIHP) recommendations for DOACrecommendations for DOA.
Measured: Day 0
Rate of compliance with the recommendations for vitamin K antagonists (VKA).
Rate of compliance with the french health authority (HAS) recommendations for VKA
Measured: Day 0
Secondary outcomes (5)
Number of pharmaceutical interventions
Number of pharmaceutical interventions regarding anticoagulant prescriptions
Measured: Day 0
description of pharmaceutical interventions
description of pharmaceutical interventions
Measured: Day 0
Evaluation of the morbi-mortality
Mortality, re-hospitalizations at 30 days, characterization of bleeding complications, characterization of thrombotic complications
Measured: Day 0
Description of the evolution of the plasma dosage of DOAC and the international normalized ratio (INR) and analysis of the operative delay
Value of preoperative DOAC plasma dosage, value of INR dosage pre- and post-op, analysis of the operative delay
Measured: Day 0
description of the population
age, weight, height, body mass index, comorbidities
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Feb 2022
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants; Circulating, Hemorrhagic DisorderStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286671
- Sponsor's protocol ID
- LOCAL/2022/CC-01
- Acronym
- ANTICOGER
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Management of Curative Anticoagulants in the Geriatric Perioperative Unit in Patient Hospitalized for Femoral Neck Fracture.
- ClinicalTrials.gov ID
- NCT05286671
- Acronym / sponsor ID
- ANTICOGER / LOCAL/2022/CC-01
- Keywords
- older patients, anticoagulant, femoral neck fractures, clinical pharmacy service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 18 Mar 2022 (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.
Pilot study to evaluate the management of curative anticoagulant prescriptions pre- and postoperatively in elderly patients hospitalized for femoral neck fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients aged 75 years and older, hospitalized in the geriatric perioperative unit from November 18, 2019 to June 30, 2021, for a hip fracture and with curative anticoagulant therapy prescription at entry.
Key inclusion criteria (4 listed)
- Patient 75 years or older
- Hospitalized in the geriatric perioperative unit for a femoral neck fracture between 18/11/2019 and 30/06/2021
- Treated with a curative anticoagulant at entry
- Patient enrolled in or receiving a social security plan
Key exclusion criteria (2 listed)
- Orthopedic patient housed in the geriatric perioperative unit
- Patient who objected to the use of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of compliance with the recommendations for direct oral anticoagulants (DOAC)..
Time frame: Day 0
Rate of compliance with the french working group on perioperative haemostasis (GIHP) recommendations for DOACrecommendations for DOA.
Rate of compliance with the recommendations for vitamin K antagonists (VKA).
Time frame: Day 0
Rate of compliance with the french health authority (HAS) recommendations for VKA
5 secondary outcomes
Number of pharmaceutical interventions
Time frame: Day 0
description of pharmaceutical interventions
Time frame: Day 0
Evaluation of the morbi-mortality
Time frame: Day 0
Description of the evolution of the plasma dosage of DOAC and the international normalized ratio (INR) and analysis of the operative delay
Time frame: Day 0
description of the population
Time frame: Day 0
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 26 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Anticoagulants; Circulating, Hemorrhagic Disorder
Not yet recruiting
MEdication Counselling Models for Outpatient oRal antIcoaguLation
Anticoagulants; Circulating, Hemorrhagic Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anticoagulants; Circulating, Hemorrhagic Disorder and Femoral Neck 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 4 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 26 Apr 2022. 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?
Rate of compliance with the recommendations for direct oral anticoagulants (DOAC).. (time frame: Day 0). The study lists 2 primary outcomes in all. 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 26 Apr 2022.